Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

June 23, 2014 updated by: Klaus Vennick Marcussen, Rigshospitalet, Denmark

Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery

Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC.

In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used routineously after major abdominal surgery.

Recently new devices has been designed, which give the opportunity tip deliver continuously CPAP with out interruptions because of presumed better comfort. Therefore better patient compliance.

No studies to date have investigated the possible benefit of using continuously helm CPAP versus the traditional intermittent mask CPAP after major abdominal surgery.

The investigators' study will investigate if there are any benefits with continuously Helm CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Christian R Mortensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective major abdominal surgery

Exclusion Criteria:

  • Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Continuously Helm CPAP
Continuously helm CPAP for 6 hours
Device: Continuously helm CPAP
6 hours
Other: Intermittent Mask CPAP
Intermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative.
Device: Intermittent Mask CPAP
10min every 2 hour for 18 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2/FiO2
Time Frame: 24 hours
Measured 6,12 and 18 hours after surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
V/Q mismatch
Time Frame: 24 hours
V/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative.
24 hours
Postoperative complications
Time Frame: 30 days
Pulmonal complications defined as; needs of oxygen therapy more than 3 days after surgery, pneumonia and x-ray verified atelektases within 30 days after surgery.
30 days
Length of stay
Time Frame: 30 days
Length of stay
30 days
Admittance to the intensive care unit
Time Frame: 30 days
If needed. Cause and length of stay in the intensive care unit i recorded.
30 days
Mortality
Time Frame: 30 days
Mortality
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total CPAP therapy time
Time Frame: 24 timer
Measured in total minutes
24 timer
CPAP interruptions
Time Frame: 24 timer
Length and cause of the interruptions are noted
24 timer
Comfort during CPAP therapy
Time Frame: 24 timer
The comfort during CPAP therapy. Measured on an numeric rang scale from 0-10, where 0 is no discomfort and 10 is extensive discomfort during CPAP.
24 timer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Christian R Mortensen, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHPOTA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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