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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506203
• Other study ID #: HULaPaz
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2023
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Weeks to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Air Test
• Atelectases, Resorption
• Atelectasis
• Atelectasis Without Respiratory Distress Syndrome
• Lung Collapse
• Lung Diseases
• Pediatric Disorder
• Pulmonary Atelectasis
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Shock

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	Córdoba
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario La Paz	Hospital Privado de Comunidad, Hospital Universitario La Princesa

Countries where clinical trial is conducted

Argentina,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atelectasis incidence	Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25).	5 minutes
Primary	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	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
Secondary	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