The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2022-05-31

Brief Summary

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HYPOTHESIS:

During anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in patients \< 6 years old, where FRC and pulmonary closing volume may overlap. New borns and children \<1 year old are especially vulnerable.

OBJECTIVES:

1. Validate "air test" as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics.
2. Determine what other factors contribute to atelectasis development in pediatrics

METHODS:

30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks and16 years old.

Baseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after intubation during a 5 min long "air test" trial (FiO2 0.25). lung collapse will be verified by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted upon lung US verification by a blind researcher.

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Detailed Description

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Conditions

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Lung Collapse Lung Diseases Atelectasis Atelectasis Without Respiratory Distress Syndrome Atelectases, Resorption Air Test Pediatric Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Lung Collapse will be diagnosed by a blind researcher that does not know the air test results

Study Groups

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Air test

Group Type EXPERIMENTAL

Air test

Intervention Type DIAGNOSTIC_TEST

Patients will breathe 0.21 \< FiO2 \< 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.

Interventions

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Air test

Patients will breathe 0.21 \< FiO2 \< 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* General anesthesia
* Perioperative risk classification (ASA) I, II, III
* Newborns (postconceptional age\> 45 weeks) to 16 years
* Need for oral / nasotracheal intubation

Exclusion Criteria

* ASA \> III
* Basal SpO2 \< 97% on air in supine position
* Preoperative need for oxygen therapy and / or high-flow nasal cannulas
* Expected Difficult airway
* Presence of craniofacial disorders that may compromise ventilation
* Hemodynamic instability and / or need for inotropics
* History of untreated heart disease
* Presence or history of pneumothorax
* Presence of untreated congenital pulmonary disorders
* Refusal to participate in the study

Minimum Eligible Age

5 Weeks

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes