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

NCT ID: NCT01316575

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-05-31

Brief 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.

Detailed 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.

Conditions

Postoperative Pulmonary Atelectasis; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

nCPAP

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

Group Type: EXPERIMENTAL

nCPAP

Intervention Type: DEVICE

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

Low Flow Oxygen

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

Group Type: ACTIVE_COMPARATOR

Low Flow Oxygen

Intervention Type: DEVICE

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

Interventions

nCPAP

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

Intervention Type: DEVICE

Low Flow Oxygen

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal University Hospital Foundation

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

William McKay

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William P McKay, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

References

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):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.

Reference Type: BACKGROUND

PMID: 19017864 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18362624 (View on PubMed)

Kindgen-Milles D, Muller E, Buhl R, Bohner 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. doi: 10.1378/chest.128.2.821.

Reference Type: BACKGROUND

PMID: 16100174 (View on PubMed)

Other Identifiers

ANES-3

Identifier Type: -

Identifier Source: org_study_id