Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

Respiratory Insufficiency Clinical Trial

Official title:

Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02173327
• Other study ID #: RHPOTA-01
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2014
• Last updated: June 23, 2014
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: June 2014
• Source: Rigshospitalet, Denmark
• Contact: Klaus V Marcussen, MD
• Phone: 0045 27597839
• Email: marcussen_klaus[@]yahoo.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: April 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Continuously helm CPAP
6 hours
• Intermittent Mask CPAP
10min every 2 hour for 18 hours

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total CPAP therapy time	Measured in total minutes	24 timer	No
Other	CPAP interruptions	Length and cause of the interruptions are noted	24 timer	No
Other	Comfort during CPAP therapy	The 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.	24 timer	No
Primary	PaO2/FiO2	Measured 6,12 and 18 hours after surgery	24 hours	No
Secondary	V/Q mismatch	V/Q mismatch measured with ALPE essential®. Meassured preoperative, on arrival in the postoperative ward and 24 hours postoperative.	24 hours	No
Secondary	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	No
Secondary	Length of stay	Length of stay	30 days	No
Secondary	Admittance to the intensive care unit	If needed. Cause and length of stay in the intensive care unit i recorded.	30 days	No
Secondary	Mortality	Mortality	30 days	No