Management of Occult Pneumothoraces in Mechanically Ventilated Patients

NCT00530725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2021-04-27

No results posted yet for this study

Summary

Collapsed lungs are common injuries after traumatic injury that regularly cause needless deaths despite being treatable with chest tubes. Properly used these tubes can be life-saving. Unfortunately, improperly used they can cause pain, bleeding, and other fatal complications themselves. Over the last few decades with increased use of CT scanning it is apparent that many small collapsed lungs are not seen on chest X-rays, and there is little guidance for the treating Doctors as to how to treat these patients. There is almost no good data that tells us whether these smaller pneumothoraces require treatment with chest tubes or whether they can simply be closely watched. This proposal is to carry out a simple trial of randomly assigning patients who do not appear to have any symptoms or problems from their occult pneumothorax to either having a standard chest tube or to being watched. Our careful review of the medical literature indicates that the investigators cannot honestly tell patients and their families which treatment is best or required. Our audit of current practice also indicates that Doctors in Calgary and across Canada, regularly prescribe both treatments regularly but in a hap-hazard. The patients in this study will be very closely watched in the intensive care unit and if they develop any breathing problems and do not have a chest tube in, then one will be inserted. The main results that the investigators are trying to determine with this pilot study, though, is whether the investigators are able to detect appropriate patients, to recruit them into such a study, and whether the guidelines the investigators have created to manage these patients in this study will be acceptable to all the patient's care givers. This data will help us to design a future large multi-centre trial that will hopefully provide information as how best to manage this type of injured patient.

Conditions

  • Pneumothorax

Interventions

PROCEDURE

chest drainage

may be a chest tube of chest drainage procedure of any type (ie formal tube, pig-tail catheter, etc)

OTHER

close clinical observation

close clinical observation in an operating room or intensive care unit without active intervention

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    collaborator OTHER
  • Sunnybrook Health Sciences Centre

    collaborator OTHER
  • Canadian Intensive Care Foundation

    collaborator OTHER
  • London Health Sciences Centre

    collaborator OTHER
  • Université de Sherbrooke

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

  • Andrew W Kirkpatrick, MD · Canadian Trauma Trials Collaborative

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2021-01-30
Completion
2021-01-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530725 on ClinicalTrials.gov