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Prophylactic nCPAP in the PACU Following Elective Laparotomy for Bowel Surgery

Primary Purpose

Postoperative Pulmonary Atelectasis, Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nasal Continuous Positive Airway Pressure
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

Eligibility Criteria

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

Inclusion Criteria:

  • patients scheduled to undergo laparotomy for elective bowel surgery

Exclusion Criteria:

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

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasal CPAP

Low Flow Oxygen

Arm Description

The experimental group will receive nasal continuous positive airway pressure 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 oxygen gradient
The difference in the alveolar-arterial oxygen gradient between group administered nasal continuous positive airway pressure at 10cmH20 for one hour and group administered low flow oxygen by face mask at 8 litres per minute for one hour following elective bowel surgery

Secondary Outcome Measures

Number of Participants Requiring Reintubation
Number of Participants Requiring Admission to the Intensive Case Unit
Length of Stay in Hospital

Full Information

First Posted
March 2, 2014
Last Updated
October 27, 2016
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT02077842
Brief Title
Prophylactic nCPAP in the PACU Following Elective Laparotomy for Bowel Surgery
Official Title
Prophylactic Nasal Continuous Positive Airway Pressure in the Post-Anaesthesia Care Unit Following Elective Laparotomy for Bowel Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

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

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
Nasal CPAP
Arm Type
Experimental
Arm Description
The experimental group will receive nasal continuous positive airway pressure 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)
Nasal Continuous Positive Airway Pressure
Other Intervention Name(s)
Resmed, VPAP III ST-A, manufactured by ResMed LTD
Intervention Description
Nasal continuous positive airway pressure at 10 cmH2O
Intervention Type
Device
Intervention Name(s)
Low Flow Oxygen
Intervention Description
Low flow oxygen delivered via face mask at 8 litres per minute
Primary Outcome Measure Information:
Title
Alveolar-arterial oxygen gradient
Description
The difference in the alveolar-arterial oxygen gradient between group administered nasal continuous positive airway pressure at 10cmH20 for one hour and group administered low flow oxygen by face mask at 8 litres per minute for one hour following elective bowel surgery
Time Frame
1 hour after admission to the Post Anesthetic Care Unit
Secondary Outcome Measure Information:
Title
Number of Participants Requiring Reintubation
Time Frame
2 weeks
Title
Number of Participants Requiring Admission to the Intensive Case Unit
Time Frame
2 weeks
Title
Length of Stay in Hospital
Time Frame
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 laparotomy for elective 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 McKay, M.D.
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

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
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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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
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Prophylactic nCPAP in the PACU Following Elective Laparotomy for Bowel Surgery

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