Management of Occult Pneumothoraces in Mechanically Ventilated Patients
NCT00530725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2021-04-27
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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