Ventilation Strategy Reduces Postoperative Atelectasis

NCT ID: NCT01911923

Last Updated: 2014-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No CPAP/PEEP and 100 % oxygen

This is the control group

Group Type ACTIVE_COMPARATOR

No CPAP/PEEP and 100 % oxygen

Intervention Type PROCEDURE

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.

CPAP/PEEP and 30 % oxygen

This is the intervention group

Group Type EXPERIMENTAL

CPAP/PEEP and 30 % oxygen

Intervention Type PROCEDURE

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.

Interventions

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No CPAP/PEEP and 100 % oxygen

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

CPAP/PEEP and 30 % oxygen

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Västmanland

OTHER

Sponsor Role lead

Responsible Party

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Lennart Edmark

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lennart Edmark, Md

Role: PRINCIPAL_INVESTIGATOR

Landstinget Vastmaland

Locations

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Västmanlands sjukhus Köping

Köping, Västmanland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr 2008 / 251

Identifier Type: -

Identifier Source: org_study_id

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