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Completed

NCT Number: NCT02077842

Prophylactic nCPAP in the PACU 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.

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Key information

Conditions

Postoperative Pulmonary Atelectasis Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

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 laparotomy for elective 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

nasal Continuous Positive Airway Pressure

Device

Nasal continuous positive airway pressure at 10 cmH2O

Other names: Resmed, VPAP III ST-A, manufactured by ResMed LTD

Low flow oxygen

Device

Low flow oxygen delivered via face mask at 8 litres per minute

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants Requiring Reintubation

    Time frame: 2 weeks

  2. Number of Participants Requiring Admission to the Intensive Case Unit

    Time frame: 2 weeks

  3. Length of Stay in Hospital

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2014
Registry last updated
Oct 31, 2016

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.

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