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Trial record 1 of 1 for:    OPTICC
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Management of Occult Pneumothoraces in Mechanically Ventilated Patients (OPTICC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00530725
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : April 27, 2021
CHU de Quebec-Universite Laval
Sunnybrook Health Sciences Centre
Canadian Intensive Care Foundation
London Health Sciences Centre
Université de Sherbrooke
Information provided by (Responsible Party):
Andrew W Kirkpatrick, University of Calgary

Brief 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.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: chest drainage Other: close clinical observation Not Applicable

Detailed Description:

The term "Occult Pneumothorax" (OPTX), describes a pneumothorax (PTX) that while not suspected on the basis of either clinical examination or plain radiograph, is ultimately detected with thoraco-abdominal computed tomograms (CT). This situation is increasingly common in contemporary trauma care with the increased use of CT. The incidence appears to approximately 5% in injured populations presenting to hospital, with CT revealing at least twice as many PTXs as suspected on plain radiographs. While PTXs are a common and treatable (through chest drainage) cause of mortality and morbidity, there is clinical equipoise and significant disagreement regarding the appropriate treatment of the OPTX. Based on level III evidence, some authors have recommended observation without chest drainage for all but the largest OPTXs, recommendations that contravene the standard dictum for ventilated patients as recommended by the Advanced Trauma Life Support Course of the American College of Surgeons. The controversy is the greatest in the critical care unit population who require positive pressure ventilation. This is also the group for whom the highest rates of chest tube complications have been reported. Complication rates related to chest tubes in general, have been claimed in up to 21% of cases.

No previous studies have focused specifically on the population of mechanically ventilated patients. There have been only 45 reported ventilated trauma patients ever randomized to treatment or observation. Enderson found that 8 (53%) of 15 patients had PTX progression with 3 tension pneumothoraces. Brasel found that of 9 observed OPTXs, 2 progressed. Brasel concluded observation was safe, while Enderson felt chest tubes were mandatory. The investigators thus propose to carry out a prospective randomized trial to examine the need for chest drainage in small to moderate sized OPTX's, as well as the practicalities of carrying out such a study.

The experience and knowledge gained from this pilot will be intended to provide additional support to a future submission to the Canadian Institute for Health Research in order to carry out a multi-centre prospective trial involving the member institutions of the Canadian Trauma Trials Collaborative (CTTC). The investigators believe they have invested more time and effort into developing this line of investigation than any other group in the World. The investigators first reviewed the pertinent literature and subsequently retrospectively reviewed the outcomes of this entity at both this institution and with collaborators at other CTTC sites. The investigators have examined the anatomic and practical reasons as to why OPTXs are occult, as well as novel investigation methods to detect them during the initial evaluation for trauma, and documented the morbidity that may occur with their treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of the Management of Occult Pneumothoraces in Mechanically Ventilated Patients
Study Start Date : August 2006
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Active Comparator: chest drainage
This represents the best current standard of care although this is quite controversial
Procedure: chest drainage
may be a chest tube of chest drainage procedure of any type (ie formal tube, pig-tail catheter, etc)

Experimental: close observation
This is the novel approach that has some justification in the literature
Other: close clinical observation
close clinical observation in an operating room or intensive care unit without active intervention

Primary Outcome Measures :
  1. 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 [ Time Frame: admission to hospital discharge ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: admission to hospital discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00530725

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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier Affilie Universitaire de Quebec
Quebec City, Quebec, Canada, G1J 1Z4
University of Sherbrooke
Sherbrooke, Canada
Sponsors and Collaborators
University of Calgary
CHU de Quebec-Universite Laval
Sunnybrook Health Sciences Centre
Canadian Intensive Care Foundation
London Health Sciences Centre
Université de Sherbrooke
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Principal Investigator: Andrew W Kirkpatrick, MD Canadian Trauma Trials Collaborative
American College of Surgeons. Advanced trauma life support course for doctors. Committee on Trauma: Instructors' Course Manual. Chicago, 1997.
Wilson H, Ellsmere J, Talon J, Kirkpatrick A. Natural history of the occult pneumothorax in the blunt trauma patient. Journal of Trauma 59(2): 541, 2005.
Wilson H, Ellsmere J, Tallon J, Kirkpatrick A. Occult pneumothorax in the blunt trauma patient requiring surgery: a qualitative review. Journal of Trauma 59(2): 545, 2005
Kirkpatrick A, Nicolaou S. The sonographic detection of pneumothoraces (pages 227-234). In: Kharmy-Jones R, Nathens A, Stern E (editors). Thoracic Trauma and Critical Care. Boston: Kleuwer Academic Publishers. 2002.

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Responsible Party: Andrew W Kirkpatrick, Professor, University of Calgary Identifier: NCT00530725    
Other Study ID Numbers: OPTICC Trial
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan.
Keywords provided by Andrew W Kirkpatrick, University of Calgary:
occult pneumothorax
mechanical ventilation
critical care
Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases