NCT01316575

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 27, 2013

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

March 7, 2011

Results QC Date

July 20, 2012

Last Update Submit

May 2, 2018

Conditions

Postoperative Pulmonary AtelectasisSurgery

Keywords

Continuous Positive Airway PressurePostoperative ComplicationsRespiratory InsufficiencyColorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • Alveolar - Arterial Gradient

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

    1 hour following admission to PACU

Secondary Outcomes (3)

  • Number of Participants Requiring Reintubation

    Up to 2 weeks

  • Number of Participants Requiring Admission to ICU

    Up to 2 weeks

  • Length of Stay in Hospital

    Up to 2 weeks

Study Arms (2)

nCPAP

EXPERIMENTAL

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

Device: nCPAP

Low Flow Oxygen

ACTIVE COMPARATOR

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

Device: Low Flow Oxygen

Interventions

nCPAPDEVICE

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

nCPAP
Low Flow OxygenDEVICE

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

Low Flow Oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo elective laparotomy for bowel surgery

You may not qualify if:

  • age \< 18 years
  • postoperative admission to the intensive care unit
  • a history of allergy/intolerance to Ametop

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 19017864BACKGROUND

  • 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.

    PMID: 18362624BACKGROUND

  • 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.

    PMID: 16100174BACKGROUND

MeSH Terms

Conditions

Pulmonary AtelectasisPostoperative ComplicationsRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Limitations and Caveats

We made an assumption for FiO2, the respiratory quotient and barometric pressure in the alveolar air equation. We did not standardize the time between extubation and application of nCPAP.

Results Point of Contact

Title
Dr. William McKay
Organization
University of Saskatchewan
william.mckay@saskatoonhealthregion.ca
306-655-1202

Study Officials

  • William P McKay, MD

    Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 16, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 4, 2018

Results First Posted

February 27, 2013

Record last verified: 2018-05