Comparison of percutaneous single-stage dilatational tracheostomy and surgical tracheostomy in critically ill patients: A randomized controlled trial

ABSTRACT

Background:

This study was done to compare single stage percutaneous dilation tracheostomy (PDT) and open surgical tracheostomy (ST) in critically ill patients.

Methods:

A randomized controlled study was conducted on 60 critically ill patients admitted in the intensive care unit (ICU). The patients were randomized into ST or PDT group with 30 in each group. The duration of procedure and associated perioperative/postoperative complications were noted and compared.

Results:

A total of 60 critically ill patients were included with 30 each in both groups. Compared to ST, PDT had significantly lesser mean duration of procedure (5 ± 1.64 vs. 21.33 ± 4.77 min, P < 0.0001) and comparable incidence of complications (3.33% vs. 20%, P = 0.103), which included 5–10 ml of bleeding (0% vs. 13.33%), cardiac arrest (0% vs. 3.33%), atrial fibrillation (3.33% vs. 0%), and tracheoesophageal fistula (0% vs. 3.33%).

Conclusion:

PDT performed in the ICU is a quick, safe, and reliable procedure with comparable complications to ST.

INTRODUCTION

One of the most often carried out surgeries in intensive care units (ICUs) is the tracheostomy, a surgical procedure that was first documented more than 2000 years ago. In the intensive care settings, the necessity for extended mechanical ventilation and loss of consciousness are typical indications for tracheostomy.[1]

When performing tracheostomies using the conventional surgical technique on critically ill patients, the entire surgical team, operating room schedule, and transportation to operation theater are frequently necessary. A promising alternative for open surgical tracheostomy (ST) is percutaneous dilation tracheostomy (PDT). The primary benefit of PDT is that it may be carried out at the patient’s bedside in an ICU, reducing surgery, and personnel expenses as well as minimizing the risks associated with transport.[2,3,4]

PDT provides the lower rates of early postoperative complications with the same perioperative risks due to lesser rate of tissue dissection and tissue damage, improved tightness between the cannula and stoma, and also decreased bleeding and wound infection complications.[5,6,7,8,9,10,11] At present, there is option to select PDT techniques from commercial sets such as Ciaglia, Griggs, and Fantoni.[12]

The aim of this study was to compare the single-stage dilator method of percutaneous tracheostomy and open ST in critically ill patients in terms of procedural duration and complications.

METHODS

The present randomized controlled study included critically ill patients admitted in the ICU. The indications for tracheostomy were long-term mechanical ventilation or prolonged loss of consciousness.

Inclusion criteria

Patients aged ≥18 years with indication for tracheostomy.

Exclusion criteria

History of previous tracheostomy and presence of coagulopathy (which was defined as INR >1.4, platelet count <5000/ml, and activated thromboplastin time >45 s).

Patients’ randomization into two groups was done by the block randomization method, whereby 10 envelopes were made, with five envelopes labeled as A and five envelopes labeled as B. For the patients’ enrollment, each patient was allotted one envelope, and the allocated group A or B was given to the patients, where A represented group PDT and B represented group ST. Hence, the patients were divided equally into two groups as block of ten up till 60 patients were randomized into two groups with 30 patients in each group. There was no concealment of the envelope from the patient. Furthermore, there was no blinding of the procedure from the primary researcher and the statistician.

All aseptic precautions and sterility measures were followed in ICU. The patient was routinely monitored. Platelet count and coagulation profile were checked. Nasogastric feeding was stopped 4 h prior to the procedure and nasogastric tube was aspirated to reduce any chances of aspiration.

All patients were intubated and on mechanical ventilation at the time of the tracheostomy procedure. The ST was performed in the standard manner by the doctors of department of ear, nose, and throat, having a minimum experience of 1 year and should have done a minimum of 6 tracheostomies.

The percutaneous dilatational tracheostomy was performed using a commercially available disposable kit by a skilled operator having performed at least six percutaneous tracheostomies and had at least 6 months of ICU experience.

The tracheostomy was performed by the same teams. All the tracheostomies were done in ICU and the ventilator used was Carefusion Avea™ ventilator (Vyaire Medical, Mettawa, USA). Patients were premedicated with intravenous fentanyl 100–150 μg and intravenous midazolam 1–3 mg. Arterial blood gas (ABG) analysis was performed before the procedure and 1 h after the procedure. Oxygen saturation (SpO₂) was recorded preoperatively and postoperatively. Vitals were monitored throughout the procedure.

Each procedure was timed from the time of infiltration to insertion and securing of tracheostomy tube. The neck was subsequently prepared and draped in a sterile fashion and the tracheostomy tube was checked to ensure adequate cuff function and preloaded on appropriate size dilator. A planned incision was often made halfway between the sternal notch and the cricoid cartilage. After the landmarks were identified and marked, the skin was infiltrated with local anesthetic and adrenaline. Vertical incision was done. To reduce hemorrhage, the dissection was done in avascular midline plane.

The bronchoscope was introduced through an opening in the catheter mount attached to the endotracheal tube (ETT) to a point just superior to the intended level of tracheostomy (between 2 and 3 tracheal rings) and likewise, withdrawn through it. Just before tracheostomy, the ETT’s cuff was deflated, and the tube was withdrawn under direct laryngoscopy till half of the cuff lied beyond the vocal cords and half above them and the cuff was inflated again so that the tube could be maintained in that position till the tracheostomy tube was inserted and bronchoscopy and ventilation till the completion of the procedure was done through this very ETT. None of the patients were disconnected from the ventilator at the time of bronchoscopy.

A 14G sheathed introducer needle was put into the trachea after it had been palpated, and location of the needle was verified by aspirating air bubbles into fluid-filled syringe attached to the needle. The needle along with the syringe was removed. The J guidewire was then introduced through the sheath and placement into the trachea was confirmed with the bronchoscope. The sheath was removed, and the guidewire was left in place. The dilator was moisturized with saline, passed over the guiding wire and advanced into the trachea over the guidewire and then withdrawn after creating an adequately sized opening.

The preloaded tracheostomy tube was advanced as a unit (Portex^® Ultraperc^® 8 mm Single Stage Dilator Technique Kit with Tracheostomy Tube, Smiths Medical ASD Inc., United Kingdom) into the trachea over the guidewire under bronchoscopic supervision. The guidewire and guiding dilator were then withdrawn leaving tracheostomy tube in place. Without removing the ETT, suctioning was done with fresh suction catheter. The tracheostomy tube was linked to the ventilator circuit, and the ventilation-tidal volume, SpO₂, and the level of carbon dioxide that is released at the end of an exhaled breath also known as end-tidal CO2 (EtCO₂) were verified. Heart rate was monitored using electrocardiogram (ECG) as well as pulse oximeter, blood pressure was assessed using oscillometric method, SpO2 using pulse oximeter, and EtCO₂ using mainstream capnography. The monitoring was done at every 5 min interval-30 min before the start till 1 h after the procedure ended; after which an ABG analysis was done to assess for adequacy of oxygenation though the newly inserted tracheostomy tube. The carina was then seen with the bronchoscope after being introduced through the tracheostomy tube to ensure proper alignment and rule out hemorrhage. The tracheostomy tube was attached to the skin with tracheostomy tape around the neck after the trachea and bronchi were meticulously suctioned. ETT was removed. Lungs were auscultated for bilateral air entry. Chest radiograph was taken. Computed tomography was done for confirming any formation of tracheoesophageal fistula (TEF).

Perioperative and postoperative complications were noted till the patient was discharged, died or transferred to another facility.

Statistical analysis

Data were entered into a Microsoft Excel spreadsheet (Microsoft Corp, Redmond, USA) and Statistical Package for Social Sciences (SPSS) version 21.0 (IBM Corp., Chicago, USA) was used for the final analysis and Tables and graphs were made. The final data were compiled and represented in the form of number (n) and percentage (%) for categorical variables and in the form of mean with standard deviation (mean ± SD) and median with interquartile range (25^th–75^th percentiles) for quantitative variables. Kolmogorov–Smirnov test was used to determine the data normality. The Chi-square test and fisher’s exact test (“if any cell had an expected value of <5”) were used for determining the association between qualitative variables; while the quantitative and not normally distributed data were associated by using the Mann–Whitney test. P =0.05 or less was regarded as statistically significant.

RESULTS

In total, 75 patients were assessed for enrolling in the study. Fifteen patients were excluded, as eight did not meet inclusion criteria and seven declined to participate. The remaining 60 patients were randomized to undergo either PDT (n = 30) or ST (n = 30). None of the patients was lost to follow-up or discontinued intervention, and thus all 30 patients in each group were analyzed [Figure 1].

Figure 1.

Participant flow algorithm

Compared to ST, PDT had comparable mean age (41 ± 17.12 vs. 45.67 ± 18.01 years, P = 0.308) and comparable number of males (53.33% vs. 56.67%) and females (46.67% vs. 43.33%) with P = 0.795 [Table 1].

Table 1.

Comparison of demographic characteristics of the patients

Parameters	PDT	ST	Significance (P)
Age (years), mean±SD	41±17.12	45.67±18.01	0.308a
Gender, n (%)
Males	16 (53.33)	17 (56.67)	0.795b
Females	14 (46.67)	13 (43.33)

^aMann–Whitney test, ^bChi-square test. SD: Standard deviation, PDT: Percutaneous dilation tracheostomy, ST: Surgical tracheostomy

The requirement of prolonged mechanical ventilator support, with a mean intubation time of more than 10 days, was the indication for percutaneous tracheostomy. Compared to ST, PDT had significantly lesser mean duration of procedure [5 ± 1.64 vs. 21.33 ± 4.77 min, P < 0.0001; Table 2].

Table 2.

Comparison of indications for procedure and its duration

Parameters	PDT	ST	Significance (P)
Indication: Prolonged mechanical ventilation, n (%)	100	100	-
Duration of procedure (min), mean±SD	5±1.64	21.33±4.77	<0.0001

Mann–Whitney test. SD: Standard deviation, PDT: Percutaneous dilation tracheostomy, ST: Surgical tracheostomy

Complications were present in a single case of PDT (3.33%) and 6 cases of ST group (20%) without any significant difference [P = 0.103; Figure 2].

Figure 2.

Comparison of complications

A single case in the PDT group had atrial fibrillation which was an incidental finding and was linked to the procedure as it happened immediately after it – recorded on ECG in ICU. The exact cause of the development of atrial fibrillation could not be ascertained. However, it subsided on its own without any mortality.

As for the ST group, four cases had bleeding which was measured through volume in the suction container and counting the number of small gauze pieces soaked in blood (1 fully soaked small gauze piece is taken as 10 ml) – and as per it, blood loss was 5–10 ml in all four patients. A single case had cardiac arrest where it was presumed to be induced by hypoxia induced as the patient was hemodynamically stable with no ionotropic support before the procedure and a normal echocardiogram. The cardiac arrest was preceded by a phase of gradual oxygen desaturation followed by transient bradycardia with no phase of hypotension in between. A single case with prolonged tracheostomy had TEF formation which was managed with an uneventful recovery.

There were no cases of complications including pneumothorax, vocal cord paralysis, aspiration, false lumen, hypotension, and postoperative infection in any of the groups.

Compared to ST, PDT had comparable incidence of bleeding (0% vs. 13.33%), cardiac arrest (0% vs. 3.33%), atrial fibrillation (3.33% vs. 0%), and TEF (0% vs. 3.33%) with P = 0.113 [Table 3].

Table 3.

Comparison of complications after procedure

Complications	PDT, n (%)	ST, n (%)	Significance (P)
Present	1 (3.33)	6 (20)	0.103
Bleeding	0	4 (13.33)	0.113
Cardiac arrest	0	1 (3.33)
Atrial fibrillation	1 (3.33)	0
TEF	0	1 (3.33)

Fisher’s exact test. TEF: Tracheoesophageal fistula, PDT: Percutaneous dilation tracheostomy, ST: Surgical tracheostomy

DISCUSSION

The present study compared PDT and ST techniques in the perioperative and postoperative period, which is the time when insults can be fatal in critically ill patients.[13,14] The study population included critically ill patients who underwent tracheostomies in ICU at the tertiary care hospital. In the current study, randomization made sure that the demographic characteristics of the two groups were comparable and that any differences in outcomes were only attributable to the intervention and not to chance bias.

The clinical course as well as the outcomes of critically ill patients depends significantly on the timing of tracheostomy. Tracheostomy is no longer advised to be performed between the 14^th and 21^st day as previously advised. Early tracheostomy seems to shorten ICU stays and lower the risk of ventilator pneumonia and ventilator dependence. Considering the variety of ICU patients, it can be difficult to determine the precise timing and requirement for a tracheostomy. When we can assume that intubation would take more than 14 days or between the 2^nd and 7^th day, it seems advantageous to do the tracheostomy.[1] The indication for percutaneous tracheostomy was the need for prolonged mechanical ventilator support in our study. The mean duration of intubation was more than 10 days that is closer to the upper limit and indicates conservative approach. Similar findings were reported by Pauliny et al., as the duration of intubation was 8 days.[1]

As for the quickness in the procedure, in the present study, PDT group had significantly lesser mean duration of procedure than ST. Similar findings were seen in the study by Başarslan et al., as the PDT took significantly lesser duration than standard tracheostomy (P = 0.0001).[5] Kang et al. also found that PDT had significantly shorter procedure time than ST (5.2 ± 3.1 vs. 10.5 ± 5.0 min, P < 0.05).[3] Gupta et al. also reported that the duration of the procedure was significantly lesser in the PDT group than ST group (19.1 ± 11.7 vs. 28.3 ± 18.4 min, P = 0.0001).[8] In a systematic review and meta-analysis by Johnson-Obasek et al., PDT was significantly favored over ST, with odds ratio of 21.7 and P = 0.001.[7] Kwon et al. observed that surgical procedure duration was more in ST compared to PDT (39 vs. 15 min, P < 0.001).[9] Lim et al. also reported similar findings with less procedure duration in PDT than ST group (15.1 vs. 25.5 min, P < 0.01).[4] Similarly, Boran et al. found significantly different duration of surgical procedure in PDT group than ST group (28 ± 5 vs. 48 ± 12 min, P < 0.05).[12]

The shorter procedural duration (1–10 min) was possible because PDT can be easily performed at the patient’s bedside and requires just a small skin incision, minimal blunt dissection of the anterior tracheal structures. Moreover, higher numbers of ventilator-free days are achieved with percutaneous dilatational tracheostomy because it takes less time to complete the procedure and enables quicker the decision-making process.[8]

Whenever a procedure is selected, safety of the procedure is of prime importance. We found that the complications rate was statistically comparable among the two groups (P > 0.05). In comparison, previous studies found significantly reduced rates of complications with PDT. Pauliny et al.[1] reported that compared to ST, PDT group had significantly lower disintegration (0% vs. 22.2%, P < 0.001), inflammation (0% vs. 27%, P < 0.001), similar bleeding (6.5% vs. 3.2%, P > 0.05), and similar leakage between cannula and the stoma (8.7% vs. 9.5%, P > 0.05). Başarslan et al. found that the PDT had significantly lower rate of complication than ST (3.4% vs. 7%, P = 0.04).[5] PDT group had postoperative complications that included wound infection, tube dislodgement, delayed closure, tracheal stenosis, and anesthetic scar but was not significant. Moreover, in PDT and ST groups, there was no significant difference in pneumothorax, bleeding, and vocal cord paralysis. In contrast, Boran et al. reported that early complications were present in significantly more patients in PDT group (9.7% vs. 2.8%, P = 0.027) including minor bleeding (3.47% vs. 0.69%), major bleeding (2.08% vs. 0%), subcutaneous emphysema (0.69% vs. 0.69%), aspiration (2.08% vs. 0.69%), and hypotension (1.38% vs. 0.69%).[12] Similarly, even late complications were significantly more in PDT group (6.21% vs. 2.08%, P = 0.147) including wound infection (4.14% vs. 0.69%), scar formation (1.38% vs. 0.69%), and tracheal stricture (0.69% vs. 0.69%).

In the study by Gupta et al., the occurrence of minor complications was similar in PDT and ST groups, except higher occurrence of oxygen desaturation in the ST group (6.6% vs. 2.3%, P = 0.001).[8] Regarding major complications, hemorrhagic events were present in significantly more patients of ST group than PDT group (7% vs. 2.6%, P = 0.002). PDT and ST groups had similar hypotension for > 5 min (1.8% vs. 2.3%), ventilator support requirement (0.3% vs. 1.6%), vasopressor therapy requirement (1.4% vs. 0.8%), false tract (0.6% vs. 0.8%), need to perform Bronchoalveolar lavage (BAL) postprocedure (2.4% vs. 1.9%), pneumothorax (0.6% vs. 0.8%), and death during procedure (0% vs. 0.4%).

Kang et al. reported that compared to ST group, PDT group had comparable estimated blood loss (4.9 ± 5.2 vs. 4.0 ± 2.9 mL, P = 0.296), complications (11.1% vs. 20.3%, P = 0.387) such as false lumen insertion (1 vs. 1, P = 0.811), bleeding (2 vs. 9, P = 0.084), accidental decannulation (0 vs. 1, P = 0.412), tube obstruction (0 vs. 1, P = 0.412), and infection (0 vs. 2, P = 0.243).[3] Kwon et al. observed that PDT had lesser procedure-induced complications than ST group (11.5% vs. 26.3%, P = 0.039).[9] Lim et al. found lesser complications such as major bleeding (0% vs. 9.1%, 0.041), but comparable lost airway or respiratory arrest (0% vs. 2.3%, P = 0.458), stoma infection (0% vs. 4.5%, P = 0.207), and tracheal stenosis and granulation (5.8% vs. 4.5%, P = 1).[4]

There remains a mixed data as far as complications associated with PDT and ST are concerned. However, it must be mentioned here that leakage is a drawback of surgical tracheostomies since the surgical approach results in the loss of tightness as the surgeon requires adequate space to insert the cannula into the trachea visually. This allows the passing of colonized mucus from the hypopharynx – resulting in stoma inflammation. Moreover, bleeding can be common in ST. Whereas, with the percutaneous technique, there is no incidence of inflammation or disintegration since the cannula remains tightly in the bluntly dilated orifice.[8]

Overall, PDT is regarded as a simpler, quicker procedure with comparable complications as ST. The decline in the incidence of surgical site infections is a reason that minimally invasive surgical procedures have become common in multiple surgical specialties. This might be because using either approach minimizes the local tissue damage and increases relative immune function preservation.[5]

The study limitations were the small sample size. Second, only one health-care facility was used to conduct this investigation. Third, no assessment of long-term complications was done. Last, the cost implications of both techniques were not assessed as the expenses for the procedure and the study were borne by the hospital (government setup).

CONCLUSION

In conclusion, PDT performed in the ICU is a simpler, quicker procedure with comparable complications as ST. Percutaneous tracheostomy can replace the surgical route in ICUs and it is attributing to ease, quickness, and obviating the need to move the patient to the operating room.

Research quality and ethics statement

This study was approved by the Institutional Review Board/Ethics Committee at Vardhman Mahavir Medical College (VMMC) and Safdarjung Hospital, New Delhi (Approval #: IEC/VMMC/SJH/Thesis/October/2017-061; Approval date: October 30, 2017). The authors followed the applicable EQUATOR Network (http://www.equator-network.org/) guidelines, specifically the CONSORT 2010 Statement, during the conduct of this research project.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.