Prophylactic nCPAP in the PACU Following Elective Laparotomy for Bowel Surgery

October 27, 2016 updated by: William McKay, University of Saskatchewan

Prophylactic Nasal Continuous Positive Airway Pressure in the Post-Anaesthesia Care Unit Following Elective Laparotomy for Bowel Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nasal CPAP
The experimental group will receive nasal continuous positive airway pressure at 10cmH20 for one hour in the Post Anesthetic Care Unit.
Device: Nasal Continuous Positive Airway Pressure
Nasal continuous positive airway pressure at 10 cmH2O
Other Names:
  • Resmed, VPAP III ST-A, manufactured by ResMed LTD
ACTIVE_COMPARATOR: Low Flow Oxygen
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
Device: Low Flow Oxygen
Low flow oxygen delivered via face mask at 8 litres per minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar-arterial oxygen gradient
Time Frame: 1 hour after admission to the Post Anesthetic Care Unit
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
1 hour after admission to the Post Anesthetic Care Unit

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Requiring Reintubation
Time Frame: 2 weeks
2 weeks
Number of Participants Requiring Admission to the Intensive Case Unit
Time Frame: 2 weeks
2 weeks
Length of Stay in Hospital
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: William McKay, M.D., Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 2, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (ESTIMATE)

March 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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