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

March 7, 2011
January 22, 2013
April 2011
May 2012   (final data collection date for primary outcome measure)
Alveolar - Arterial Gradient [ Time Frame: 1 hour following admission to PACU ] [ Designated as safety issue: Yes ]
Alveolar - arterial gradient
Partial Pressure of Arterial Oxygen [ Time Frame: 1 hour following admission to PACU ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01316575 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate of reintubation [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)
Prophylactic Nasal Continuous Positive Airway Pressure (nCPAP) Following 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Postoperative Pulmonary Atelectasis
  • Surgery
  • Device: nCPAP
    The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
  • Device: Low Flow Oxygen
    The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
  • Experimental: nCPAP
    The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
    Intervention: Device: nCPAP
  • Active Comparator: Low Flow Oxygen
    The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
    Intervention: Device: Low Flow Oxygen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01316575
ANES-3
No
William McKay, University of Saskatchewan
University of Saskatchewan
Royal University Hospital Foundation
Principal Investigator: William P McKay, MD Professor
University of Saskatchewan
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP