Intraoperative Air-Test

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

Official title:

Incidence of Intraoperative Positive Air-Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469648
• Other study ID #: Air-Test
• Status: Completed
• Start date: March 10, 2018
• Est. completion date: April 20, 2018

Study information

• Verified date: October 2018
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse.

The aim of this study is to non-invasively describe the incidence of intraoperative atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt to describe the association between positive Air-Test and the patient´s preoperative or intraoperative variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 20, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) I-IV

• General Anesthesia

• Mechanical ventilation

Exclusion Criteria:

• age < 18 years old

• pregnancy

• patients undergoing cardiothoracic surgery

• ASA physical status V

Related Conditions & MeSH terms

• Patients With ASA Status I-III Scheduled for Surgery

Intervention

Procedure:
• Air-Test
The Air Test simply consisted in breathing room air for 5 min during anesthesia while measuring peripheral oxygen saturation by Pulse oximetry

Locations

Country	Name	City	State
Spain	Carlos Ferrando	Valencia
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 (2)

Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosdá 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. — View Citation

Ferrando C, Tusman G, Suarez-Sipmann F, León I, Pozo N, Carbonell J, Puig J, Pastor E, Gracia E, Gutiérrez A, Aguilar G, Belda FJ, Soro M. Individualized lung recruitment maneuver guided by pulse-oximetry in anesthetized patients undergoing laparoscopy: a feasibility study. Acta Anaesthesiol Scand. 2018 May;62(5):608-619. doi: 10.1111/aas.13082. Epub 2018 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with positive Air-Test	Positive Air-Test defined as SpO2 < 97% while breathing room air	During surgery