Ventilation Strategy Reduces Postoperative Atelectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01911923
Recruitment Status : Withdrawn
First Posted : July 30, 2013
Last Update Posted : August 26, 2014
Information provided by (Responsible Party):
Lennart Edmark, Landstinget Västmanland

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.

Condition or disease Intervention/treatment Phase
Pulmonary Atelectasis Procedure: No CPAP/PEEP and 100 % oxygen Procedure: CPAP/PEEP and 30 % oxygen Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.
Study Start Date : August 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: No CPAP/PEEP and 100 % oxygen
This is the control group
Procedure: 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.
Experimental: CPAP/PEEP and 30 % oxygen
This is the intervention group
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.

Primary Outcome Measures :
  1. Area of atelectasis [ Time Frame: 30 minutes ]
    The area of atelectasis is investigated by computed tomography of the lungs postoperatively

Secondary Outcome Measures :
  1. Peripheral oxygen saturation (SpO2) [ Time Frame: 2 hours ]
    SpO2 is assessed immediately after extubation and then continuously postoperatively

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01911923

Västmanlands sjukhus Köping
Köping, Västmanland, Sweden, 721 89
Sponsors and Collaborators
Region Västmanland
Principal Investigator: Lennart Edmark, Md Landstinget Vastmaland

Responsible Party: Lennart Edmark, M.D., Landstinget Västmanland Identifier: NCT01911923     History of Changes
Other Study ID Numbers: Dnr 2008 / 251
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases