The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in pneumothorax size
研究概览
简要总结
The purpose of this research is to see if people who have had a collapsed lung that has been re-expanded can be safely taken to an elevation that a person might experience while in a commercial airplane without having their lung partially collapse again, or have any symptoms such as feeling short of breath or having oxygen levels in the blood decrease while at the simulated altitude.
The investigators hypothesize that subjects who have had a collapsed lung that has been re-expanded will not have any adverse symptoms or signs while subjected to a simulated altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).
详细描述
The investigators will study patients who have been diagnosed with a unilateral traumatic pneumothorax that has been treated. Treatment for pneumothorax may consist of high-flow oxygen therapy in the case of very small or "occult" pneumothorax, or tube thoracostomy ("chest tube") in the case of larger pneumothorax. Treatment for pneumothorax will be at the discretion of the attending trauma surgeon. Once the pneumothorax has radiographically resolved, the chest tube, if used, has been removed, and prior to discharge from the hospital, subjects will undergo a two hour stay in a hypobaric chamber. In the first phase of the study, they will undergo a two hour stay in a hypobaric chamber at a barometric pressure of 565mm Hg, simulating the change in pressure from Salt Lake City to a cruising airliner. If subjects in the first phase do not suffer any adverse events, the investigators will proceed with the second phase. In the second phase of the study, subjects will undergo a two hour stay in the hypobaric chamber at a barometric pressure of 471mm Hg, simulating the change in pressure from sea level to a cruising airliner. Prior to the hypobaric exposure, and at the conclusion of the two hours under hypobaric conditions, single view chest radiographs will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient status on trauma surgery service
- •An established diagnosis of pneumothorax with a traumatic etiology (patients with iatrogenic pneumothorax from attempted central venous line placement will be considered to have a traumatic etiology)
- •Age ≥ 18 at the time of injury
排除标准
- •Unable to give informed consent
- •Pneumothorax which does not satisfactorily resolve after treatment with tube thoracostomy and requires operative intervention such as video assisted thoracoscopic surgery (VATS) or thoracotomy
- •Pneumothorax requiring tube thoracostomy where the tube has been removed for < 4 or > 48 hours
- •Head injury with GCS < 15 at time of evaluation for study
- •Other injuries or conditions which would preclude participant's ability to remain in chamber for two hours
- •NYHA class III or IV heart failure, active coronary artery disease, arrhythmias, pacemakers, implantable cardiac defibrillator, pulmonary hypertension, claustrophobia
- •Severe obstructive or restrictive lung disease
- •Chronic hypoxemia requiring supplemental oxygen
- •Hypoxemia for any reason (pulmonary contusion, atelectasis, pneumonia, etc.) requiring > 3 liters supplemental oxygen at the time of entry into the study
- •Inability to tolerate the confines of the chamber
结局指标
主要结局
Change in pneumothorax size
时间窗: baseline and 2 hours
Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours
次要结局
未报告次要终点
研究者
Sarah Majercik
MD, MBA, FACS
Intermountain Health Care, Inc.