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CompletedNCT03469648Updated Oct 2, 2018

Intraoperative Air-Test

An observational study in Patients With ASA Status I-III Scheduled for Surgery, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients With ASA Status I-III Scheduled for Surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study included consecutive patients who were scheduled for surgery with general anesthesia and mechanical ventilation

Inclusion criteria

  • American Society of Anesthesiologist (ASA) I-IV
  • General Anesthesia
  • Mechanical ventilation

Exclusion criteria

Exclusion Criteria:

  • age \< 18 years old
  • pregnancy
  • patients undergoing cardiothoracic surgery
  • ASA physical status V
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No

Interventions

  • ProcedureAir-Test

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

05

What researchers measure

Primary outcomes

  1. Patients with positive Air-Test

    Positive Air-Test defined as SpO2 \< 97% while breathing room air

    Time frame: During surgery

06

Study locations

2 sites
  • Carlos Ferrando
    Valencia, 46010, Spain
  • Department of Anesthesia and Critical Care; Hospital Clinico Universitario
    Valencia, 46010, Spain
07

References and documents

Publications

  • Ferrando C, Tusman G, Suarez-Sipmann F, Leon I, Pozo N, Carbonell J, Puig J, Pastor E, Gracia E, Gutierrez 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. PubMed 29377061 ↗
  • 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. PubMed 28554935 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03469648
Lead sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Responsible party
Carlos Ferrando (Anesthesiologist, Fundación para la Investigación del Hospital Clínico de Valencia) — Principal investigator
First posted
Mar 19, 2018
Start date
Mar 10, 2018
Primary completion
Apr 10, 2018
Completion
Apr 20, 2018
Last update
Oct 2, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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