Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00530725
Study type Interventional
Source University of Calgary
Contact
Status Completed
Phase N/A
Start date August 2006
Completion date January 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06022081 - Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax N/A
Recruiting NCT02907866 - Use of Endobronchial Ultrasound Scope (EBUS) Transducer to Identify Pneumothorax-A Feasibility Study
Terminated NCT03034421 - Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema N/A
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Completed NCT02619591 - Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax N/A
Recruiting NCT05342675 - Effect of Rapid Rollover on Pneumothorax After CT-Guided Lung Biopsy N/A
Recruiting NCT05910112 - Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
Completed NCT03656406 - Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery
Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Recruiting NCT03728491 - Education and Training Competences in Thoracic Ultrasound N/A
Recruiting NCT05407974 - Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax N/A
Completed NCT01670942 - Hypobaria and Traumatic Pneumothorax N/A
Terminated NCT00969423 - Chronic Pain After Video-assisted Thoracoscopic Surgery (VATS) Surgery for Pneumothorax N/A
Completed NCT05904574 - Effectiveness of the Autologous Blood Patch Method in Lung Biopsies
Completed NCT03327688 - Point-of-care Ultrasound in Finland N/A
Completed NCT05963945 - Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Completed NCT05222568 - Effect of the Minimum Bronchial Cuff Volume of Left-sided Double-lumen Endotracheal Tube for One-lung Ventilation on the Change of the Bronchial Cuff Pressure During Lateral Positioning in Thoracic Surgery
Not yet recruiting NCT05121233 - Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures Phase 4
Completed NCT03064659 - Driving Pressure And EFL in Adult Cardiac Surgery N/A
Recruiting NCT02090205 - Mechanical Ventilation During Cardiac Surgery N/A