Pneumothorax Clinical Trial
— OPTICCOfficial title:
Prospective Randomized Trial of the Management of Occult Pneumothoraces in Mechanically Ventilated Patients
Verified date | April 2021 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | January 30, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. age >= 18 years old 2. small to moderate sized occult pneumothorax identified on chest or abdominal CT scan 3. no chest drain in-situ 4. no hemothorax which warrants drainage in the judgment of attending clinician 5. no respiratory compromise in the judgment of the attending clinician Exclusion Criteria: 1. not expected to survive 2. large occult pneumothorax 3. pneumothorax obvious on plain CXR (not occult) 4. respiratory distress in the judgment of the attending clinician 5. pre-existing chest drain in-situ |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Centre Hospitalier Affilie Universitaire de Quebec | Quebec City | Quebec |
Canada | University of Sherbrooke | Sherbrooke | |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Canadian Intensive Care Foundation, CHU de Quebec-Universite Laval, London Health Sciences Centre, Sunnybrook Health Sciences Centre, Université de Sherbrooke |
Canada,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Outcome Variables: In ventilated patients with small to moderate sized occult PTXs, the rate of respiratory distress will not differ between those treated with chest thoracostomy tubes and those not treated but simply observed | admission to hospital discharge | ||
Secondary | Observation of small OPTXs in ventilated patients will not increases the rates of Emergency chest drainage, Death, tracheostomy, ARDS, Ventilator associated pneumonia (VAP), or the Abdominal Compartment Syndrome (ACS) | admission to hospital discharge |
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