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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Pediatric Disorder; Atelectasis; Lung Collapse; Atelectasis Without Respiratory Distress Syndrome; Atelectases, Resorption; Air Test
• Intervention / Treatment: Diagnostic test: Air test

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina
    • Hospital Privado de Comunidad
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air test	Diagnostic test: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Collaborators: Hospital Universitario La Princesa; Hospital Privado de Comunidad

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: atelectasis; pediatric; non-invasive; lung collapse; air test
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Infant, Premature, Diseases; Lung Diseases; Pulmonary Atelectasis; Shock; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: HULaPaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be published in a peer reviewed journal
• IPD Sharing Time Frame: Upon publishment in journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No