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

Not Applicable

Completed

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

• Registration Number: NCT04506203
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Study Start: 2020-09-10
• Primary Completion: 2021-08-31
• Study Completion: 2022-05-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Air test	Air test	-

Primary Outcome Measures

Name	Time	Method
Atelectasis incidence	5 minutes	Assess incidence of SpO2 \< 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 \< 0.25).
Accuracy of Pediatric Air test trial	5 minutes	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Privado de Comunidad; 🇦🇷 Córdoba, Argentina

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain