Skip to main content
OpenTrials
Completed

NCT Number: NCT01316575

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pulmonary Atelectasis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pulmonary Atelectasis Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NCPAP

Device

The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.

Low flow oxygen

Device

The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.

Primary outcomes

  1. Alveolar - Arterial Gradient

    Time frame: 1 hour following admission to PACU

    The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen

Secondary outcomes

  1. Number of Participants Requiring Reintubation

    Time frame: Up to 2 weeks

  2. Number of Participants Requiring Admission to ICU

    Time frame: Up to 2 weeks

  3. Length of Stay in Hospital

    Time frame: Up to 2 weeks

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Royal University Hospital Foundation

Registry information

Official study title

Prophylactic Nasal Continuous Positive Airway Pressure (nCPAP) Following Bowel Surgery

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2011
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.