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Ventilation Strategy Reduces Postoperative Atelectasis

Primary Purpose

Pulmonary Atelectasis

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
No CPAP/PEEP and 100 % oxygen
CPAP/PEEP and 30 % oxygen
Sponsored by
Region Västmanland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atelectasis

Eligibility Criteria

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

Inclusion Criteria:

  1. Adult patients up to 75 years of age.
  2. American Society of Anesthesiologists (ASA) physical status class I-III.
  3. Be able to climb two flight of stairs without stopping.
  4. SpO2 of ≥ 94% when breathing air in the supine position.
  5. A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of < 31.

Exclusion Criteria:

  1. Patients with chronic obstructive pulmonary disease.
  2. Smokers.
  3. Ex smokers if smoked more than 5 pack years.
  4. Overt heart failure
  5. Known or predicted difficult intubation.

Sites / Locations

  • Västmanlands sjukhus Köping

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No CPAP/PEEP and 100 % oxygen

CPAP/PEEP and 30 % oxygen

Arm Description

This is the control group

This is the intervention group

Outcomes

Primary Outcome Measures

Area of atelectasis
The area of atelectasis is investigated by computed tomography of the lungs postoperatively

Secondary Outcome Measures

Peripheral oxygen saturation (SpO2)
SpO2 is assessed immediately after extubation and then continuously postoperatively

Full Information

First Posted
July 26, 2013
Last Updated
August 25, 2014
Sponsor
Region Västmanland
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1. Study Identification

Unique Protocol Identification Number
NCT01911923
Brief Title
Ventilation Strategy Reduces Postoperative Atelectasis
Official Title
Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis.
Detailed Description
During general anesthesia, the combination of reduced functional residual capacity (FRC), high inspiratory oxygen fraction (FIO2), and airway closure are the main factors implicated in the atelectasis, shunt and shunt-like effects that account for the majority of the impaired oxygenation seen during general anesthesia. Previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (CPAP) followed by a positive end-expiratory pressure (PEEP).During emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. Even a recruitment maneuver, followed by ventilation with 100% oxygen with a PEEP/CPAP of 10 cm H2O until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (ZEEP).This failure may have been caused by the presence of lung regions with high oxygen concentrations. The investigators hypothesized that by inducing and discontinuing anesthesia during CPAP/PEEP and deliberately reducing FIO2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. To test our hypothesis, the investigators studied 1) a control group with no CPAP/PEEP and a FIO2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on CPAP/PEEP of 6 cmH2O from induction to extubation and that received an FIO2 of 1.0 until extubation and then an FIO2 of 0.3 via a facemask while on CPAP after extubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
No CPAP/PEEP and 100 % oxygen
Arm Type
Active Comparator
Arm Description
This is the control group
Arm Title
CPAP/PEEP and 30 % oxygen
Arm Type
Experimental
Arm Description
This is the intervention group
Intervention Type
Procedure
Intervention Name(s)
No CPAP/PEEP and 100 % oxygen
Intervention Description
This is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled.
Intervention Type
Procedure
Intervention Name(s)
CPAP/PEEP and 30 % oxygen
Intervention Description
During all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used.
Primary Outcome Measure Information:
Title
Area of atelectasis
Description
The area of atelectasis is investigated by computed tomography of the lungs postoperatively
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Peripheral oxygen saturation (SpO2)
Description
SpO2 is assessed immediately after extubation and then continuously postoperatively
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients up to 75 years of age. American Society of Anesthesiologists (ASA) physical status class I-III. Be able to climb two flight of stairs without stopping. SpO2 of ≥ 94% when breathing air in the supine position. A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of < 31. Exclusion Criteria: Patients with chronic obstructive pulmonary disease. Smokers. Ex smokers if smoked more than 5 pack years. Overt heart failure Known or predicted difficult intubation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Edmark, Md
Organizational Affiliation
Landstinget Vastmaland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Västmanlands sjukhus Köping
City
Köping
State/Province
Västmanland
ZIP/Postal Code
721 89
Country
Sweden

12. IPD Sharing Statement

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Ventilation Strategy Reduces Postoperative Atelectasis

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