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Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

Primary Purpose

Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Continuously helm CPAP
Intermittent Mask CPAP
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Continuously Helm CPAP

Intermittent Mask CPAP

Arm Description

Continuously helm CPAP for 6 hours

Intermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative.

Outcomes

Primary Outcome Measures

PaO2/FiO2
Measured 6,12 and 18 hours after surgery

Secondary Outcome Measures

V/Q mismatch
V/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative.
Postoperative complications
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.
Length of stay
Length of stay
Admittance to the intensive care unit
If needed. Cause and length of stay in the intensive care unit i recorded.
Mortality
Mortality

Full Information

First Posted
June 18, 2014
Last Updated
June 23, 2014
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02173327
Brief Title
Helm CPAP Versus Mask CPAP After Major Abdominal Surgery
Official Title
Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuously Helm CPAP
Arm Type
Other
Arm Description
Continuously helm CPAP for 6 hours
Arm Title
Intermittent Mask CPAP
Arm Type
Other
Arm Description
Intermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative.
Intervention Type
Device
Intervention Name(s)
Continuously helm CPAP
Intervention Description
6 hours
Intervention Type
Device
Intervention Name(s)
Intermittent Mask CPAP
Intervention Description
10min every 2 hour for 18 hours
Primary Outcome Measure Information:
Title
PaO2/FiO2
Description
Measured 6,12 and 18 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
V/Q mismatch
Description
V/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative.
Time Frame
24 hours
Title
Postoperative complications
Description
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.
Time Frame
30 days
Title
Length of stay
Description
Length of stay
Time Frame
30 days
Title
Admittance to the intensive care unit
Description
If needed. Cause and length of stay in the intensive care unit i recorded.
Time Frame
30 days
Title
Mortality
Description
Mortality
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Total CPAP therapy time
Description
Measured in total minutes
Time Frame
24 timer
Title
CPAP interruptions
Description
Length and cause of the interruptions are noted
Time Frame
24 timer
Title
Comfort during CPAP therapy
Description
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.
Time Frame
24 timer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus V Marcussen, MD
Phone
0045 27597839
Email
marcussen_klaus@yahoo.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lara SP Henningsen, Nurse
Phone
0045 20252406
Email
lara.siri.pris.henningsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian R Mortensen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian R Mortensen, MD
Phone
0045 35458736
Email
christian.risby@regionh.dk
First Name & Middle Initial & Last Name & Degree
Christian R Mortensen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35429325
Citation
Osterkamp JTF, Strandby RB, Henningsen L, Marcussen KV, Thomsen T, Mortensen CR, Achiam MP, Jans O. Comparing the effects of continuous positive airway pressure via mask or helmet interface on oxygenation and pulmonary complications after major abdominal surgery: a randomized trial. J Clin Monit Comput. 2023 Feb;37(1):63-70. doi: 10.1007/s10877-022-00857-7. Epub 2022 Apr 16.
Results Reference
derived

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Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

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