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

Patients With ASA Status I-III Scheduled for Elective Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650037
• Other study ID #: AirTest
• Status: Completed
• Phase: N/A
• First received: December 28, 2015
• Last updated: January 7, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: November 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients With ASA Status I-III Scheduled for Elective Surgery

Intervention

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

Locations

Country	Name	City	State
Spain	Department of Anesthesia and Critical Care; Hospital Clinico Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography.	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.	35 minutes post-surgery	Yes