NCT02077842

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

87
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 May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

March 2, 2014

Last Update Submit

October 27, 2016

Conditions

Postoperative Pulmonary AtelectasisSurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Number of Participants Requiring Reintubation

    2 weeks

  • Number of Participants Requiring Admission to the Intensive Case Unit

    2 weeks

  • Length of Stay in Hospital

    2 weeks

Study Arms (2)

Nasal CPAP

EXPERIMENTAL

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

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

Nasal Continuous Positive Airway PressureDEVICE

Nasal continuous positive airway pressure at 10 cmH2O

Also known as: Resmed, VPAP III ST-A, manufactured by ResMed LTD
Nasal CPAP
Low Flow OxygenDEVICE

Low flow oxygen delivered via face 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 laparotomy for elective 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

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

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

  • 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

  • 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

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • William McKay, M.D.

    Faculty

    PRINCIPAL INVESTIGATOR

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 2, 2014

First Posted

March 4, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

CA(1)