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Clinical Trials/NCT02548416
NCT02548416CompletedNot Applicable

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

Region Västmanland1 site in 1 country24 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Measurement of aeras with different aeration in the particular CT scan.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

PEEP group

Active Comparator

Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using positive end-expiratory pressure.

Intervention: Positive end-expiratory pressure (Procedure)

Control group zero PEEP

Active Comparator

Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using zero end-expiratory pressure.

Intervention: Control group, zero PEEP (Procedure)

Outcomes

Primary Outcomes

Measurement of aeras with different aeration in the particular CT scan.

Time Frame: 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

Time Frame: 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 Outcomes

  • Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)(Within 2 hours perioperatively, 15 minutes after extubation.)
  • Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)(Within 1-2 hours, just before emergence from anesthesia. At end of surgery but before emergence from anaesthesia, at the same time as the lungs are investigated by computed tomography.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erland Ostberg

M.D.

Region Västmanland

Study Sites (1)

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