Comparing the Effectiveness of Lung Expansion Therapy in Adult Human Subjects
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|ClinicalTrials.gov Identifier: NCT02892773|
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : November 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atelectasis||Device: Incentive Spirometry Device: EzPAP® Positive Airway Pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||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.|
|Official Title:||A Randomized Controlled Trial Comparing the Effectiveness of Lung Expansion Therapy Following Upper Abdominal Surgery in Adult Human Subjects|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||November 12, 2018|
|Actual Study Completion Date :||November 12, 2018|
Incentive Spirometry Group
Device: Incentive Spirometry
A respiratory therapist will provide instruction on Incentive Spirometry (I.S.) procedure performance before supervised therapy and monitoring begins.
Active Comparator: EzPAP® Positive Airway Pressure Group
Device: EzPAP® Positive Airway Pressure
A respiratory therapist will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins.
- Ventral and Dorsal end-expiratory lung impedance redistribution of ventilation [ Time Frame: 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.
- 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)
- Incidences of post-operative pulmonary complications [ Time Frame: Two years ]
Investigators will search participant's electronic medical record for documentation of atelectasis, hypoxemia, pneumonia, and acute respiratory failure. Data will be recorded in an electronic code book and total count for respective pulmonary complications will be used to quantify incidence of respective pulmonary complications.
• Statistical analysis
- Chi square for independence or Fisher's Exact Probability test will be applied to test for statistical significance.
- Respective post-operative complication will be reported as frequency (n)
- Relative Risk and Odds Ratio will be reported for effect size.
- Alpha set at ≤ 0.05 (two-tailed)
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): NCT02892773
|United States, Virginia|
|University of Virginia Medical Center|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Daniel D Rowley, MSc RRT-ACCS||Pulmonary Diagnostics & Respiratory Therapy Services, University of Virginia Medical Center|