Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

NCT ID: NCT02173327

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuously Helm CPAP

Continuously helm CPAP for 6 hours

Group Type OTHER

Continuously helm CPAP

Intervention Type DEVICE

6 hours

Intermittent Mask CPAP

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

Group Type OTHER

Intermittent Mask CPAP

Intervention Type DEVICE

10min every 2 hour for 18 hours

Interventions

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Continuously helm CPAP

6 hours

Intervention Type DEVICE

Intermittent Mask CPAP

10min every 2 hour for 18 hours

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Klaus Vennick Marcussen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian R Mortensen, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Klaus V Marcussen, MD

Role: CONTACT

0045 27597839

Lara SP Henningsen, Nurse

Role: CONTACT

0045 20252406

Facility Contacts

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Christian R Mortensen, MD

Role: primary

0045 35458736

References

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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.

Reference Type DERIVED
PMID: 35429325 (View on PubMed)

Other Identifiers

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RHPOTA-01

Identifier Type: -

Identifier Source: org_study_id

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