Hazard 1991.
| Methods | RCT Randomization method: no details Methods of concealment were unclear Blinding unclear |
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| Participants | Number of participants/procedures (PDT/ST): 22/24 / 24/24 Gender male/female: PDT: 12/10 (NS) ST: 13/11 (NS) Mean age (years): PDT: 61 ± 19 (NS) ST: 65 ± 18 (NS) Population: medical/surgical ICU APACHE II Score: PDT: no details ST: no details SAPS Score: PDT: 11.9 ± 4.6 (NS) ST: 11.8 ± 4.2 (NS) Period intubation up to tracheotomy (days): PDT: 7.7 ± 3.9 (NS) ST: 9.2 ± 3.2 (NS) Total number of operators (PDT/ST): three general surgeons, four cardiothoracic surgeons and one neurosurgeon Experience of the operators (PDT / ST): board‐certified and experienced in the performance of tracheostomy/investigators, or by house officers under their direct supervision Procedure Setting (location PDT performed/location ST performed): bedside/bedside and operating room (numbers no details) Inclusion and exclusion criteria were clearly defined in the text Inclusion criteria: adult patients who required an oral or nasal endotracheal tube for > 5 days Exclusion criteria: age < 15 yrs, high potential for extubation within the next 4 days, the presence of any haemostatic defect (platelet count < 40,000/mm3, or activated partial thromboplastin time or prothrombin time >1.5 times the control value) that could not be corrected by replacement of blood components, any gross anatomic distortion of the trachea, as by tumour, thyromegaly, or scarring from prior tracheostomy, any evidence of infection in the soft tissues of the neck Treatment and control groups were adequately described at entry (sex, age, SAPS score, principle diagnosis, coagulation status) |
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| Interventions | Technique/method: PDT: Ciaglia, multiple dilator ST: different (the specific techniques used by these individuals were not under the control of the investigators) Monitoring: none Use of bronchoscopic guidance for PDT: no PDT: local anaesthetic combined with intravenous narcotic or benzodiazepine sedation ST: general or local anaesthesia |
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| Outcomes | Survival rate (%): PDT: 54 ST: 33 Days up to decannulation: PDT: 16.9 ± 12.9 ST: 22.0 ± 10.0 Lowest PaO2 (%): PDT: 96 ± 5 ST: 92 ± 11 Stay in the hospital (days): PDT: no details ST: no details Operation time (min): PDT: 4.3 ± 2.2 (NS) ST: 13.5 ± 7.3 (NS) Complication rate Length of follow‐up: 12 weeks Lost to follow‐up (total, PDT, open) (%): no details |
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| Notes | No cross‐over | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization method: no details |
| Allocation concealment (selection bias) | Unclear risk | Methods of concealment were unclear |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Subject blinded: Unclear__X__ Physician blinded: No__X__ Outcome assessor blinded: Unclear__X__ |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes of patients who withdrew or were excluded after allocation were EITHER detailed separately OR included in an intention‐to‐treat analysis OR the text stated there were (no withdrawals) |
| Selective reporting (reporting bias) | Low risk | No evidence of selective or incomplete reporting |
| Other bias | Unclear risk | Treatment and control groups were adequately described at entry Patient selection: No _X_ Withdrawls: No _X_ Post‐random exclusion: No _X_ Intension‐to‐treat analysis: Yes _X_ |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Subject blinded: Unclear__X__ Physician blinded: No__X__ |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessor blinded: Unclear__X__ |