Management of Occult Pneumothoraces in Mechanically Ventilated Patients (OPTICC)
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ClinicalTrials.gov Identifier: NCT00530725 |
Recruitment Status :
Recruiting
First Posted : September 17, 2007
Last Update Posted : November 12, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumothorax | Procedure: chest drainage Other: close clinical observation | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 300 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 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: chest drainage
This represents the best current standard of care although this is quite controversial
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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
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Other: close clinical observation
close clinical observation in an operating room or intensive care unit without active intervention |
- 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 ]
- 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 ]

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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:
- age >= 18 years old
- small to moderate sized occult pneumothorax identified on chest or abdominal CT scan
- no chest drain in-situ
- no hemothorax which warrants drainage in the judgment of attending clinician
- no respiratory compromise in the judgment of the attending clinician
Exclusion Criteria:
- not expected to survive
- large occult pneumothorax
- pneumothorax obvious on plain CXR (not occult)
- respiratory distress in the judgment of the attending clinician
- pre-existing chest drain in-situ

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 ClinicalTrials.gov identifier (NCT number): NCT00530725
Contact: Andrew W Kirkpatrick, MD | 403-944-2888 | Andrew.Kirkpatrick@albertahealthservices.ca | |
Contact: Jimmy Xiao | 403-944-8750 | jimmy.xiao@albertahealthservices.ca |
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 |
Principal Investigator: | Andrew W Kirkpatrick, MD | Canadian Trauma Trials Collaborative |
Responsible Party: | Andrew W Kirkpatrick, Professor, University of Calgary |
ClinicalTrials.gov Identifier: | NCT00530725 |
Other Study ID Numbers: |
OPTICC Trial |
First Posted: | September 17, 2007 Key Record Dates |
Last Update Posted: | November 12, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan. |
occult pneumothorax mechanical ventilation critical care pneumothorax thoracostomy |
Pneumothorax Pleural Diseases Respiratory Tract Diseases |