Helm CPAP Versus Mask CPAP After Major Abdominal Surgery
Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 24, 2014
June 1, 2014
1 year
June 18, 2014
June 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
PaO2/FiO2
Measured 6,12 and 18 hours after surgery
24 hours
Secondary Outcomes (5)
V/Q mismatch
24 hours
Postoperative complications
30 days
Length of stay
30 days
Admittance to the intensive care unit
30 days
Mortality
30 days
Other Outcomes (3)
Total CPAP therapy time
24 timer
CPAP interruptions
24 timer
Comfort during CPAP therapy
24 timer
Study Arms (2)
Continuously Helm CPAP
OTHERContinuously helm CPAP for 6 hours
Intermittent Mask CPAP
OTHERIntermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative.
Interventions
Eligibility Criteria
You may qualify if:
- Elective major abdominal surgery
You may not qualify if:
- Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 35429325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian R Mortensen, MD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 24, 2014
Study Start
November 1, 2013
Primary Completion
November 1, 2014
Study Completion
April 1, 2016
Last Updated
June 24, 2014
Record last verified: 2014-06