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

Madrid Health Service

Status: Completed

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

Treatments: Diagnostic Test: Air test

Study type: Interventional

Funder types: Other

Identifiers

NCT04506203

HULaPaz

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 5 weeks to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Air test

Experimental group

Treatment:

Diagnostic Test: Air test