search
Back to results

Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)

Primary Purpose

Postoperative Pulmonary Atelectasis, Surgery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nCPAP
Low Flow Oxygen
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pulmonary Atelectasis focused on measuring Continuous Positive Airway Pressure, Postoperative Complications, Respiratory Insufficiency, Colorectal Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled to undergo elective laparotomy for bowel surgery

Exclusion Criteria:

  • age < 18 years
  • postoperative admission to the intensive care unit
  • a history of allergy/intolerance to Ametop

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    nCPAP

    Low Flow Oxygen

    Arm Description

    The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.

    The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.

    Outcomes

    Primary Outcome Measures

    Alveolar - Arterial Gradient
    The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen

    Secondary Outcome Measures

    Number of Participants Requiring Reintubation
    Number of Participants Requiring Admission to ICU
    Length of Stay in Hospital

    Full Information

    First Posted
    March 7, 2011
    Last Updated
    May 2, 2018
    Sponsor
    University of Saskatchewan
    Collaborators
    Royal University Hospital Foundation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01316575
    Brief Title
    Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)
    Official Title
    Prophylactic Nasal Continuous Positive Airway Pressure (nCPAP) Following Bowel Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Saskatchewan
    Collaborators
    Royal University Hospital Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether prophylactic nasal continuous positive airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative pulmonary function following elective bowel surgery. The investigators hypothesize that one hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2) when compared to the standard treatment of low flow oxygen applied by face mask.
    Detailed Description
    Post-operative pulmonary complications, such as hypoxemia, pneumonia and respiratory failure, occur in 5-10% of patients following abdominal surgery. These post-operative pulmonary complications result in increased morbidity, mortality, ICU admission, length of hospital stay and resource use. CPAP has shown to be an effective treatment for hypoxemia following abdominal surgery. It decreases atelectasis formation the risk of pneumonia. Application of nCPAP to treat hypoxemic respiratory failure following thoraco-abdominal surgery has shown to decrease endotracheal intubation. Nasal CPAP has shown to be effective prophylaxis following elective cardiac and thoraco-abdominal aortic surgery. It reduces the incidence of hypoxemia, pneumonia, re-intubation and re-admission to the ICU. It has also shown to decrease the length of hospital stay. The use of nCPAP immediately post-operatively in the PACU following abdominal surgery has not been evaluated. Nasal CPAP is better tolerated than full face mask CPAP. It allows for effective clearance of respiratory secretions, improved communication and decreases claustrophobic sensation. The PACU is a transition period from general anaesthesia into the post-operative recovery phase. During this time, residual anaesthetic causes decreased level of consciousness and sub-optimal respiratory effort. Reversal agent for neuromuscular blockade has often not reached its peak effect. Inadequate pain control may further decrease respiratory effort. This transition period may be when maximal atelectasis of alveolar lung units occurs. This time period may be optimal for the application of nCPAP for prophylaxis against hypoxemia. It may improve post-operative pulmonary function which could decrease post-operative morbidity, mortality, length of hospital stay and resource use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pulmonary Atelectasis, Surgery
    Keywords
    Continuous Positive Airway Pressure, Postoperative Complications, Respiratory Insufficiency, Colorectal Surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nCPAP
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
    Arm Title
    Low Flow Oxygen
    Arm Type
    Active Comparator
    Arm Description
    The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
    Intervention Type
    Device
    Intervention Name(s)
    nCPAP
    Intervention Description
    The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
    Intervention Type
    Device
    Intervention Name(s)
    Low Flow Oxygen
    Intervention Description
    The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
    Primary Outcome Measure Information:
    Title
    Alveolar - Arterial Gradient
    Description
    The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen
    Time Frame
    1 hour following admission to PACU
    Secondary Outcome Measure Information:
    Title
    Number of Participants Requiring Reintubation
    Time Frame
    Up to 2 weeks
    Title
    Number of Participants Requiring Admission to ICU
    Time Frame
    Up to 2 weeks
    Title
    Length of Stay in Hospital
    Time Frame
    Up to 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled to undergo elective laparotomy for bowel surgery Exclusion Criteria: age < 18 years postoperative admission to the intensive care unit a history of allergy/intolerance to Ametop
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William P McKay, MD
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19017864
    Citation
    Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.
    Results Reference
    background
    PubMed Identifier
    18362624
    Citation
    Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829.
    Results Reference
    background
    PubMed Identifier
    16100174
    Citation
    Kindgen-Milles D, Muller E, Buhl R, Bohner H, Ritter D, Sandmann W, Tarnow J. Nasal-continuous positive airway pressure reduces pulmonary morbidity and length of hospital stay following thoracoabdominal aortic surgery. Chest. 2005 Aug;128(2):821-8. doi: 10.1378/chest.128.2.821.
    Results Reference
    background

    Learn more about this trial

    Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)

    We'll reach out to this number within 24 hrs