Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery

Not Applicable

Completed

• Conditions: Atelectasis

• Registration Number: NCT02548416
• Lead Sponsor: Region Västmanland

Brief Summary

Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.

The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2015-11
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2017-11-19
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy subjects, American Society of Anesthesiology (ASA) I-II.
• Patients scheduled for non-abdominal day case surgery under general anaesthesia.

Exclusion Criteria

• ASA class III or higher.
• Body Mass Index (BMI) 30 or higher.
• Arterial oxygen saturation (SpO2) <96% breathing air.
• Chronic Obstructive Pulmonary Disease (COPD).
• Ischaemic heart disease.
• Known or anticipated difficult airway.
• Active smokers and ex-smokers with a history of more than 6 pack years.
• Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurement of aeras with different aeration in the particular CT scan.	Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.	The areas of different aeration are assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter\^2 and as a percentage of the total lung area in the particular scan.
Area of atelectasis expressed as centimeter^2	Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.	The area of atelectasis in the lungs is assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter\^2 and as a percentage of the total lung area in the particular scan.

Secondary Outcome Measures

Name	Time	Method
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)	Within 2 hours perioperatively, 15 minutes after extubation.	Arterial blood gas samples will be drawn and analyzed 15 minutes after emergence from anesthesia and extubation.

Trial Locations

Locations (1)

Region Västmanland; 🇸🇪 Köping, Sweden