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

NCT04506203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitario La Princesa

    collaborator UNKNOWN

  • Hospital Privado de Comunidad

    collaborator UNKNOWN

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Weeks
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2021-08-31
Completion
2022-05-31

Countries

  • Argentina
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506203 on ClinicalTrials.gov