Management of Occult Pneumothoraces in Mechanically Ventilated Patients (OPTICC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Calgary
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Québec, CHU de Québec
Sunnybrook Health Sciences Centre
Canadian Intensive Care Foundation
Information provided by (Responsible Party):
Andrew W Kirkpatrick, University of Calgary
ClinicalTrials.gov Identifier:
NCT00530725
First received: September 13, 2007
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Pneumothorax
Procedure: chest drainage
Other: close clinical observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of the Management of Occult Pneumothoraces in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2006
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
careful clinical follow-up in an operating room or intensive care unit without active intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530725

Contacts
Contact: Andrew W Kirkpatrick, MD 403-944-2888 Andrew.Kirkpatrick@albertahealthservices.ca
Contact: Jimmy Xiao 403-944-8750 jimmy.xiao@albertahealthservices.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Andrew W Kirkpatrick, MD    403-944-2888    Andrew.Kirkpatrick@albertahealthservices.ca   
Contact: Jimmy Xiao    403-944-8750    jimmy.xiao@albertahealthservices.ca   
Principal Investigator: Andrew W Kirkpatrick, MD         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Sandro Rizoli, MD, PhD    416-480-5255    sandro.rizoli@sunnybrook.ca   
Principal Investigator: Sandro Rizoli, MD, PhD         
Canada, Quebec
Centre Hospitalier Affilie Universitaire de Quebec Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Vincent Trottier, MD    (418)649-0252    r8155@hotmail.com   
Principal Investigator: Vincent Trottier, MD         
Canada
University of Sherbrooke Recruiting
Sherbrooke, Canada
Contact: Marco Sirois, MD       Marco.sirois@usherbrooke.ca   
Principal Investigator: Marco Sirois, MD         
Sponsors and Collaborators
University of Calgary
Centre Hospitalier Universitaire de Québec, CHU de Québec
Sunnybrook Health Sciences Centre
Canadian Intensive Care Foundation
Investigators
Principal Investigator: Andrew W Kirkpatrick, MD Canadian Trauma Trials Collaborative
  More Information

Publications:
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.

Responsible Party: Andrew W Kirkpatrick, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00530725     History of Changes
Other Study ID Numbers: OPTICC Trial
Study First Received: September 13, 2007
Last Updated: July 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
occult pneumothorax
mechanical ventilation
critical care
pneumothorax
thoracostomy

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014