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The Air Test: A New Simple, Non-invasive Method to Diagnose Anesthesia-induced 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.
ClinicalTrials.gov Identifier: NCT02650037
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Anesthesia-induced atelectasis persist in the postoperative period but are not usually diagnosed because imaging techniques are required. The aim of the study is to determine whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a general anesthesia.

Condition or disease Intervention/treatment
Patients With ASA Status I-III Scheduled for Elective Surgery Procedure: Air Test

Study Design

Study Type : Observational
Actual Enrollment : 181 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estudio de validación de la pulsioximetría Como método diagnóstico no Invasivo de Atelectasia Pulmonar y de la Efectividad de la Maniobra de Capacidad Vital Para la reversión de la Atelectasia Durante el Postoperatorio
Study Start Date : November 2014
Primary Completion Date : February 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: Air Test
    The Air Test simply consisted in breathing room air for 5 min on arrival into the postoperative anesthesia care unit while measuring peripheral oxygen saturation by Pulse oximetry

Outcome Measures

Primary Outcome Measures :
  1. Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography. [ Time Frame: 35 minutes post-surgery ]
    After arrival to the post-surgery unit, patients received supplemental oxygen through a venturi mask with flow adjusted to approximate a FiO2 of 0.5 during the first 30 minutes. The SpO2 measure was made removing the oxygen mask and leaving the patients to breath room air for at least for 5 minutes.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study included all patients with ASA status I-III scheduled for elective surgery.
Criteria

Inclusion Criteria:

  • ASA I-III
  • Scheduled for elective surgery

Exclusion Criteria:

  • age of <18 years
  • pregnant women
  • previous lung resection
  • local-regional anesthesia
  • cardio-thoracic anesthesia
  • preoperative room air SpO2 less than 97%
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02650037


Locations
Spain
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia