Prophylactic nCPAP in the PACU Following Elective Laparotomy for Bowel Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077842
• Other study ID #: 13-192
• Status: Completed
• Phase: N/A
• First received: March 2, 2014
• Last updated: October 27, 2016
• Start date: May 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Pulmonary Atelectasis
• Pulmonary Atelectasis
• Surgery

Intervention

Device:
• Nasal Continuous Positive Airway Pressure
Nasal continuous positive airway pressure at 10 cmH2O
• Low Flow Oxygen
Low flow oxygen delivered via face mask at 8 litres per minute

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829. Review. — View Citation

Kindgen-Milles D, Müller E, Buhl R, Böhner H, Ritter D, Sandmann W, Tarnow J. Nasal-continuous positive airway pressure reduces pulmonary morbidity and length of hospital stay following thoracoabdominal aortic surgery. Chest. 2005 Aug;128(2):821-8. — View Citation

Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-9. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar-arterial oxygen gradient	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	1 hour after admission to the Post Anesthetic Care Unit	Yes
Secondary	Number of Participants Requiring Reintubation		2 weeks	Yes
Secondary	Number of Participants Requiring Admission to the Intensive Case Unit		2 weeks	Yes
Secondary	Length of Stay in Hospital		2 weeks	Yes