Management of Occult Pneumothoraces in Mechanically Ventilated Patients (OPTICC)

April 26, 2021 updated by: Andrew W Kirkpatrick, University of Calgary

Prospective Randomized Trial of the Management of Occult Pneumothoraces in Mechanically Ventilated Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Sherbrooke, Canada
        • University of Sherbrooke
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Centre hospitalier affilié universitaire de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
admission to hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
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
admission to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Sunnybrook Health Sciences Centre
CHU de Quebec-Universite Laval
Université de Sherbrooke
London Health Sciences Centre
Canadian Intensive Care Foundation

Investigators

  • Principal Investigator: Andrew W Kirkpatrick, MD, Canadian Trauma Trials Collaborative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTICC Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumothorax

Clinical Trials on chest drainage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe