Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

Not Applicable

• Conditions: Respiratory Insufficiency
• Interventions: Device: Continuously helm CPAP; Device: Intermittent Mask CPAP

• Registration Number: NCT02173327
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-23
• Last Update Submitted: 2014-06-23
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24
• Primary Completion: 2014-11
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuously Helm CPAP	Continuously helm CPAP	Continuously helm CPAP for 6 hours
Intermittent Mask CPAP	Intermittent Mask CPAP	Intermittent Mask CPAP for 10minuttes every 2 hours in a 18 hours period postoperative.

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2	24 hours	Measured 6,12 and 18 hours after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark