Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

Study Overview
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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.

Official Title
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Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: Continuously helm CPAP
* Device: Intermittent Mask CPAP


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| V/Q mismatch | V/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative. | 24 hours | 
| 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. | 30 days | 
| Length of stay | Length of stay | 30 days | 
| Admittance to the intensive care unit | If needed. Cause and length of stay in the intensive care unit i recorded. | 30 days | 
| Mortality | Mortality | 30 days |