Prophylactic nCPAP in the PACU Following Elective Laparotomy for Bowel Surgery
|ClinicalTrials.gov Identifier: NCT02077842|
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pulmonary Atelectasis Surgery||Device: Nasal Continuous Positive Airway Pressure Device: Low Flow Oxygen||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Nasal Continuous Positive Airway Pressure in the Post-Anaesthesia Care Unit Following Elective Laparotomy for Bowel Surgery|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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 Name: 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
- 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
- Number of Participants Requiring Reintubation [ Time Frame: 2 weeks ]
- Number of Participants Requiring Admission to the Intensive Case Unit [ Time Frame: 2 weeks ]
- Length of Stay in Hospital [ Time Frame: 2 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077842
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||William McKay, M.D.||Faculty|