Trial record 2 of 21 for:    Open Studies | "Pulmonary Atelectasis"

Ventilation Strategy Reduces Postoperative Atelectasis

This study is currently recruiting participants.
Verified October 2013 by Landstinget Västmanland
Sponsor:
Information provided by (Responsible Party):
Lennart Edmark, Landstinget Västmanland
ClinicalTrials.gov Identifier:
NCT01911923
First received: July 26, 2013
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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 Intervention
Pulmonary Atelectasis
Procedure: No CPAP/PEEP and 100 % oxygen
Procedure: CPAP/PEEP and 30 % oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.

Resource links provided by NLM:


Further study details as provided by Landstinget Västmanland:

Primary Outcome Measures:
  • Area of atelectasis [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    The area of atelectasis is investigated by computed tomography of the lungs postoperatively


Secondary Outcome Measures:
  • Peripheral oxygen saturation (SpO2) [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    SpO2 is assessed immediately after extubation and then continuously postoperatively


Estimated Enrollment: 13
Study Start Date: August 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911923

Locations
Sweden
Västmanlands sjukhus Köping Recruiting
Köping, Västmanland, Sweden, 721 89
Contact: Mats Enlund, M.D., Ph.D.    21 173000 ext +46    mats.enlund@ltv.se   
Sponsors and Collaborators
Landstinget Västmanland
Investigators
Principal Investigator: Lennart Edmark, Md Landstinget Vastmaland
  More Information

No publications provided

Responsible Party: Lennart Edmark, M.D., Landstinget Västmanland
ClinicalTrials.gov Identifier: NCT01911923     History of Changes
Other Study ID Numbers: Dnr 2008 / 251
Study First Received: July 26, 2013
Last Updated: October 12, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014