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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04506203
Enrollment
108
Registered
2020-08-10
Start date
2020-09-10
Completion date
2022-05-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTAir 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.

Sponsors

Hospital Universitario La Princesa
CollaboratorUNKNOWN
Hospital Privado de Comunidad
CollaboratorUNKNOWN
Hospital Universitario La Paz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Lung Collapse will be diagnosed by a blind researcher that does not know the air test results

Eligibility

Sex/Gender
ALL
Age
5 Weeks to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Atelectasis incidence5 minutesAssess incidence of SpO2 \< 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 \< 0.25).
Accuracy of Pediatric Air test trial5 minutesAssess 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

MeasureTime frameDescription
Atelectasis risk factors assessment5 minutesDetermine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery
Atelectasis severity5 minutesDetermine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score

Countries

Argentina, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026