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

This study has been completed.
Sponsor:
Collaborator:
Royal University Hospital Foundation
Information provided by (Responsible Party):
William McKay, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01316575
First received: March 7, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Postoperative Pulmonary Atelectasis
Surgery
Device: nCPAP
Device: Low Flow Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Nasal Continuous Positive Airway Pressure (nCPAP) Following Bowel Surgery

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Alveolar - Arterial Gradient [ Time Frame: 1 hour following admission to PACU ] [ Designated as safety issue: Yes ]
    Alveolar - arterial gradient


Secondary Outcome Measures:
  • Number of Participants Requiring Reintubation [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants Requiring Admission to ICU [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: Yes ]
  • Length of Stay in Hospital [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nCPAP
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
Device: nCPAP
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
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
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316575

Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation
Investigators
Principal Investigator: William P McKay, MD Professor
  More Information

Publications:
Responsible Party: William McKay, Anesthesiologist, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01316575     History of Changes
Other Study ID Numbers: ANES-3
Study First Received: March 7, 2011
Results First Received: July 20, 2012
Last Updated: January 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Continuous Positive Airway Pressure
Postoperative Complications
Respiratory Insufficiency
Colorectal Surgery

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014