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

Study Overview
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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: Validate air test as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics. 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.

Official Title
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The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study

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

Intervention / Treatment
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* Diagnostic Test: Air test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Weeks
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air test<br> | Diagnostic Test: Air test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atelectasis incidence | Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25). | 5 minutes | 
| Accuracy of Pediatric Air test trial | Assess incidence of lung collapse (hence atelectasis incidence) 15 minutes after anesthesia induction using an air test (FiO2 < 0.25). Collapse blind validation using lung US | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atelectasis risk factors assessment | Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery | 5 minutes | 
| Atelectasis severity | Determine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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air test, atelectasis, pediatric, non-invasive, lung collapse