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
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
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
NCT ID
NCT01316575
First Posted
March 7, 2011
Last Updated
May 2, 2018
Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
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
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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
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Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)
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