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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
Sponsor:
Collaborator:
Draeger Medical, Inc
Information provided by (Responsible Party):
Daniel D Rowley, University of Virginia

Brief Summary:

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:

  1. Incentive Spirometry (I.S.) lung expansion therapy
  2. 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.
Device: Incentive Spirometry

A respiratory therapist will provide instruction on Incentive Spirometry (I.S.) procedure performance before supervised therapy and monitoring begins.

  • Study participants will be asked to take 10 deep breaths through the I.S.'s mouthpiece, followed by a 60 second pause.
  • The 10-breath cycle will be repeated 3 times per therapy session.
  • Each I.S. therapy session will last about 15 minutes, 3 times per day.
  • Lung monitoring and deep breathing measurements will occur during a scheduled I.S. sessions on day 1, 3, and 5 after surgery.

Active Comparator: 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.
Device: EzPAP® Positive Airway Pressure

A respiratory therapist will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins.

  • Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.
  • The 10-breath cycle will be repeated 3 times.
  • Each EzPAP® therapy sessions will last about 15 minutes, 3 times per day.
  • Lung monitoring will occur during a scheduled EzPAP® sessions on day 1, 3, and 5 after surgery.




Primary Outcome Measures :
  1. 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.

    • 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)


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Human subjects 18 - 79 years of age
  • Post-operative upper abdominal surgery

Examples:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Draeger Medical, Inc
Investigators
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Principal Investigator: Daniel D Rowley, MSc RRT-ACCS Pulmonary Diagnostics & Respiratory Therapy Services, University of Virginia Medical Center

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel D Rowley, MSc RRT-ACCS, University of Virginia
ClinicalTrials.gov Identifier: NCT02892773     History of Changes
Other Study ID Numbers: 19029
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Intend to submit overall study findings to peer reviewed medical journal after study completion.
Keywords provided by Daniel D Rowley, University of Virginia:
electrical impedance tomography
incentive spirometry
EzPAP
lung volume
atelectasis
positive airway pressure
pulmonary complication
abdominal surgery
end-expiratory lung volume
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases