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

NCT04506203 | Completed

• 1 other identifier: HULaPaz
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 3

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

Conditions

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

Keywords

air test; atelectasis; pediatric; non-invasive; lung collapse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Atelectasis risk factors assessment

  5 minutes

• Atelectasis severity

  5 minutes

Study Arms (1)

Air test

EXPERIMENTAL

Diagnostic Test: Air test

Interventions

Air test 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.

Air test

Eligibility Criteria

• Age: 5 Weeks - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• Hospital Universitario La Princesa: collaborator
• Hospital Privado de Comunidad: collaborator

Study Sites (3)

Hospital Privado de Comunidad

Córdoba, Argentina

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Lung Collapse will be diagnosed by a blind researcher that does not know the air test results
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 10, 2020
• Primary Completion: August 31, 2021
• Study Completion: May 31, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publishment in journal

Locations

AR (1); ES (2)