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The Air Test: A New Simple, Non-invasive Method to Diagnose Anesthesia-induced Atelectasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier:
NCT02650037
First received: December 28, 2015
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
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 Intervention
Patients With ASA Status I-III Scheduled for Elective Surgery Procedure: Air Test

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia:

Primary Outcome Measures:
  • 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.


Enrollment: 181
Study Start Date: November 2014
Study Completion Date: November 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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