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

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Positive end-expiratory pressure
Control group, zero PEEP
Sponsored by
Region Västmanland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring Atelectasis, Positive End-Expiratory Pressure, Oxygenation, Anaesthesia, Computed tomography

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Region Västmanland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PEEP group

Control group zero PEEP

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area of atelectasis expressed as centimeter^2
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.
Measurement of aeras with different aeration in the particular CT scan.
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.

Secondary Outcome Measures

Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Arterial blood gas samples will be drawn and analyzed at the same time as the computed tomography scan will be undertaken.
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Arterial blood gas samples will be drawn and analyzed 15 minutes after emergence from anesthesia and extubation.

Full Information

First Posted
September 1, 2015
Last Updated
November 19, 2017
Sponsor
Region Västmanland
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1. Study Identification

Unique Protocol Identification Number
NCT02548416
Brief Title
Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Official Title
Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Västmanland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
Atelectasis, Positive End-Expiratory Pressure, Oxygenation, Anaesthesia, Computed tomography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP group
Arm Type
Active Comparator
Arm Description
Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using positive end-expiratory pressure.
Arm Title
Control group zero PEEP
Arm Type
Active Comparator
Arm Description
Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using zero end-expiratory pressure.
Intervention Type
Procedure
Intervention Name(s)
Positive end-expiratory pressure
Intervention Description
Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure is set to 6 or 8 cm H20 (8 if BMI>25) in the intervention group. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Intervention Type
Procedure
Intervention Name(s)
Control group, zero PEEP
Intervention Description
Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Zero PEEP is used. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Primary Outcome Measure Information:
Title
Area of atelectasis expressed as centimeter^2
Description
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.
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.
Title
Measurement of aeras with different aeration in the particular CT scan.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Description
Arterial blood gas samples will be drawn and analyzed at the same time as the computed tomography scan will be undertaken.
Time Frame
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.
Title
Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
Description
Arterial blood gas samples will be drawn and analyzed 15 minutes after emergence from anesthesia and extubation.
Time Frame
Within 2 hours perioperatively, 15 minutes after extubation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Edmark
Organizational Affiliation
Region Västmanland
Official's Role
Study Director
Facility Information:
Facility Name
Region Västmanland
City
Köping
Country
Sweden

12. IPD Sharing Statement

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

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