| Methods |
Parallel randomised controlled clinical trial
Randomisation ratio: VATS:thoracostomy = 10:8
Country: USA
Number of study centres: 1 |
| Participants |
N recruited = 18
N randomised = 18
N reported outcomes = 18
Mean age = 64.5 months (study in children)
Gender m/f = 10/8
N tube thoracostomy = 8
N VATS = 10
Inclusion criteria:
0 to 18 years of age Evidence of community‐acquired pneumonia with parapneumonic effusion Effusion greater than 1.5 cm (widest pleura‐pleura collection on CT scan) Clinically judged to require evacuation (fever, tachypnoea, persistent chest or abdominal pain, or leukocytosis)
Exclusion criteria:
Hospital‐acquired pneumonia Previous drainage procedure Uncorrected cardiac disease Known immunocompromise Pre‐existing bronchopleural fistula Contraindications to fibrinolytic therapy Suspected non‐bacterial infection
|
| Interventions |
Treatment before study: All participants had received antibiotic therapy that was appropriate for the suspected micro‐organisms prior to enrolment.
Titration period and treatment:
After diagnosis, participants were randomised to receive either conventional thoracostomy or VATS (with dissection of loculations and debridement) with subsequent tube thoracostomy. For participants in the thoracostomy group, a follow‐up chest X‐ray was performed within 24 hours of tube placement. If significant clearance of the collection was seen, then the tube was left in place until it drained < 1 mL/kg/day for > 24 hours. If significant clearance was not seen, then fibrinolytic therapy (reteplase) was commenced. Reteplase (1/50 mL normal saline) was administered through the chest tube. The dose given was 1 mL/kg with a minimum dose of 25 mL and a maximum dose of 100 mL 4 times a day. Reteplase was continued for as long as drainage remained above 1 mL/kg/day for a maximum of 5 days. If the drainage remained > 1 mL/kg/day after 5 days, a CT‐guided pigtail catheter was placed and fibrinolytic therapy given. If the effusion persisted after pigtail catheter placement, the participant was then evaluated to receive either VATS or open thoracotomy. For participants in the VATS group, the chest drain remained in place until drainage was < 1 mL/kg/day and there was resolution of the effusion. If the effusion persisted, then a similar protocol to the thoracostomy group was followed with fibrinolytic therapy, pigtail catheter placement, and repeat VATS/thoracotomy.
|
| Outcomes |
Time of outcome measurements: not reported
Primary outcome(s):
Secondary outcome(s):
Other outcome(s):
-
Facility charges
USD 12,988 (10,799 to 15,606) (VATS) versus USD 18,447 (13,931 to 29,562) (thoracostomy); P = 0.016
-
Physician charges
-
Total charges
USD 19,714 (17,325 to 23,000) (VATS) versus USD 21,947 (17,895 to 37,458) (thoracostomy); P = 0.004
|
| Notes |
Language of publication: English
Publication status: peer‐reviewed journal
Type of funding: not reported
Conflicts of interest: none reported
Stated aim for study: "This trial of paediatric patients with community‐acquired pneumonia and associated parapneumonic processes compared primary video‐assisted thoracoscopic surgery with conventional thoracostomy drainage." |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Using a random number method in groups of 10 generated by a Spectrum Health research nurse" |
| Allocation concealment (selection bias) |
Unclear risk |
Not mentioned |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding not possible. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not mentioned |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were no missing outcome data. |
| Selective reporting (reporting bias) |
Low risk |
No protocol published. However, all outcomes in methods were included in results. |
| Other bias |
Unclear risk |
Funding source not reported. |
