A Randomized Controlled Trial Comparing the Effectiveness of Lung Expansion Therapy Following Upper Abdominal Surgery in Adult Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Ventral and Dorsal end-expiratory lung impedance redistribution of ventilation
研究概览
简要总结
The purpose of this study is to better understand how air is spread throughout study participants' lungs after abdominal surgery by comparing two lung inflation treatments:
- Incentive Spirometry (I.S.) lung expansion therapy
- EzPAP® lung expansion therapy.
Lung expansion therapy is routinely used after upper abdominal surgery. Taking deep breaths after surgery helps lungs to stay inflated. At the University of Virginia, it is at the physician's discretion as to which treatment will be used to help with deep breathing lung inflation therapy after surgery. The investigators would like to know which of the lung inflation therapies is better at helping inflate participants' lungs.
The investigators will be using a device called Electrical Impedance Tomography (EIT) to measure how effectively air spreads in participants' lungs. This device is not currently approved by the Food and Drug Administration (FDA) for the purpose used in this study, and therefore, it is considered investigational.
Investigators are inviting eligible participants to consider participating in this study because doctors order Incentive Spirometry as a standard of care following upper abdominal surgery. Information gained from monitoring how air is spread throughout participants' lungs will help investigators to determine if there is a clinical difference and benefit when comparing Incentive Spirometry and EzPAP lung expansion therapies.
详细描述
Investigators will use a convenience sampling scheme to identify potential study participants. Documentation of informed consent will be recorded. Electrical Impedance Tomography (EIT), which provides non-invasive and radiation free monitoring, will be used to monitor and measure regional distribution of ventilation during Incentive Spirometry (I.S.) and EzPAP® lung expansion therapy. The PulmoVista 500 EIT device has a reported high patient safety profile and poses minimal patient risk.
The potential benefit for study participants will not be realized directly since the investigators' aim is to only monitor regional distribution of ventilation in response to I.S. or EzPAP® lung expansion therapy. While I.S. is considered to be a standard of post-operative care, there is low quality evidence documenting I.S. effectiveness in preventing pulmonary complications after upper abdominal surgery.
Loss of dorsal lung volume (i.e., atelectasis) is an example of a post-operative pulmonary complication. EzPAP® is a lung expansion therapy that is used as an alternative to I.S. lung expansion therapy for increasing dorsal regional lung volume (i.e., Functional Residual Volume [FRC]) in an effort to prevent or reverse atelectasis. When expiratory positive airway pressures of 5, 10, and 15 cmH2O was administered to a small group of healthy human subjects, medical researchers identified that a positive pressure of 15 cmH2O was associated with the greatest FRC increase when compared to zero pressure and baseline FRC measurements.
While study participants may not benefit directly from this study, investigators anticipate that important information will be gained from EIT monitoring of regional distribution of ventilation. Future upper abdominal post-operative surgical patients may benefit from this study's findings as investigators hope to advance clinical understanding associated with these therapies with use of EIT.
Procedure set-up and device calibration will occur according to Draeger provided PulmoVista 500 EIT training and operation manual instructions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant and Care Provider will be masked from electrical impedance tomography distribution of ventilation recording during lung expansion therapy to reduce risk of performance bias.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Human subjects 18 - 79 years of age
- •Post-operative upper abdominal surgery
- •Laparotomy
- •Biliodigestive anastomosis
- •Cholecystectomy
- •Enterectomy
- •Esophagectomy
- •Gastrectomy
- •Hepatectomy
- •Pancreatectomy
- •Unassisted spontaneous breathing
- •Attending surgeon's approval
- •Anticipated post-operative hospital length of stay greater than 3 days
- •Documentation of written informed consent
- •Ability to sign consent
排除标准
- •Less than 18 or greater than 79 years of age
- •Anticipated post-operative hospital length of stay less than 3 days
- •Body mass index > 50
- •Excessive chest hair
- •Inability to obtain written informed consent
- •Inability to follow verbal instructions
- •Pregnancy-self reported
- •uncontrolled body movements
- •Insertion of an artificial airway
- •Hemodynamic instability
- •Loss of skin integrity at site where EIT electrodes and belt are projected to come into contact (i.e., chest burns, open wounds/lesions, etc...).
- •Chest tube or dressings that prohibit placement of EIT electrodes and belt
- •Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator [ICD]), diaphragm pacer, or when device compatibility is in doubt.)
- •Invasive or non-invasive mechanical ventilation support
- •Unstable spinal lesions or fractures
- •Untreated pneumothorax
- •Active hemoptysis
- •Esophageal surgery
- •Decision to withhold life-sustaining treatment
研究组 & 干预措施
Incentive Spirometry Group
- Participant will be asked to take 10 deep breaths through the mouthpiece of an incentive spirometer, followed by a 60 second pause.
- This cycle will be repeated two more times.
- A Respiratory Therapist will coach participants three times per day.
- Each duration of Incentive Spirometry will last about 15 minutes.
干预措施: Incentive Spirometry (Device)
EzPAP® Positive Airway Pressure Group
- Participant will be coached by a Respiratory Therapist to breathe through the mouthpiece of an EzPAP® device for 10 breaths, followed by a 60 second pause.
- This cycle will be repeated two more times.
- The Respiratory Therapist will coach participants three times per day.
- Each duration of EzPAP® therapy will last about 15 minutes.
干预措施: EzPAP® Positive Airway Pressure (Device)
结局指标
主要结局
Ventral and Dorsal end-expiratory lung impedance redistribution of ventilation
时间窗: Two years
EIT will be used to measure ventral and dorsal change in end-expiratory lung impedance before and after lung expansion therapy. Ventral and Dorsal lung impedance measurement is displayed on the EIT device as a percent (zero to 100). Investigators will record values into an electronic code book before and after lung expansion therapy. The difference between measured values will be used to quantify ventral and dorsal redistribution of ventilation. * Statistical analysis * An independent samples t-test or Mann-Whitney U test will be applied to determine if a statistically significant mean difference exists between groups. * Data will be reported as mean (SD) and 95% CI or median (IQR) depending upon normality of distribution. * Effect size = r (small effect \</= 0.1; medium effect = 0.3; Large effect \>/= 0.5 * Alpha set at ≤ 0.05 (two-tailed)
次要结局
- Incidences of post-operative pulmonary complications(Two years)
研究者
Daniel D Rowley
MSc RRT-ACCS
University of Virginia