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Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02173327
Enrollment
102
Registered
2014-06-24
Start date
2013-11-30
Completion date
2016-04-30
Last updated
2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency

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.

Interventions

DEVICEContinuously helm CPAP

6 hours

DEVICEIntermittent Mask CPAP

10min every 2 hour for 18 hours

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FiO224 hoursMeasured 6,12 and 18 hours after surgery

Secondary

MeasureTime frameDescription
Postoperative complications30 daysPulmonal 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 stay30 daysLength of stay
Admittance to the intensive care unit30 daysIf needed. Cause and length of stay in the intensive care unit i recorded.
Mortality30 daysMortality
V/Q mismatch24 hoursV/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative.

Other

MeasureTime frameDescription
Comfort during CPAP therapy24 timerThe 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.
CPAP interruptions24 timerLength and cause of the interruptions are noted
Total CPAP therapy time24 timerMeasured in total minutes

Countries

Denmark

Contacts

Primary ContactKlaus V Marcussen, MD
marcussen_klaus@yahoo.dk0045 27597839
Backup ContactLara SP Henningsen, Nurse
lara.siri.pris.henningsen@regionh.dk0045 20252406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026