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

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02650037
• Collaborator: (none)
• Enrollment: 181
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 15.1

Study Details

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	Phase
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: Nov 1, 2014
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Outcome Measures

Primary Outcome Measures

1. Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography. [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesia and Critical Care; Hospital Clinico Universitario	Valencia		Spain	46010

Sponsors and Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hedenstierna G, Tokics L, Strandberg A, Lundquist H, Brismar B. Correlation of gas exchange impairment to development of atelectasis during anaesthesia and muscle paralysis. Acta Anaesthesiol Scand. 1986 Feb;30(2):183-91.
• Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.
• Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. Review.

• Responsible Party: Carlos Ferrando, MD, PhD, Fundación para la Investigación del Hospital Clínico de Valencia
• ClinicalTrials.gov Identifier: NCT02650037
• Other Study ID Numbers: AirTest
• First Posted: Jan 8, 2016
• Last Update Posted: Jan 8, 2016
• Last Verified: Jan 1, 2016

Study Results

No Results Posted as of Jan 8, 2016