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

NCT02650037 | Completed

• 1 other identifier: AirTest
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With ASA Status I-III Scheduled for Elective Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Air Test PROCEDURE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included all patients with ASA status I-III scheduled for elective surgery.

You may qualify if:

• ASA I-III
• Scheduled for elective surgery

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Valencia, Valencia, 46010, Spain

Location

Related Publications (4)

• 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.

  PMID: 23385321 BACKGROUND

• Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.

  PMID: 12821566 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.1986.tb02393.x.

  PMID: 3085429 BACKGROUND

• Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosda R, Valls P, Villena A, Serralta F, Jurado A, Carrizo J, Navarro J, Parrilla C, Romero JE, Pozo N, Soro M, Villar J, Belda FJ. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study. BMJ Open. 2017 May 29;7(5):e015560. doi: 10.1136/bmjopen-2016-015560.

  PMID: 28554935 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 8, 2016
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

ES (1)