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Completed

NCT Number: NCT04506203

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

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.

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Key information

Conditions

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

Age range

5 week–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Privado de Comunidad, Córdoba, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Atelectasis incidence

    Time frame: 5 minutes

    Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25).

  2. Accuracy of Pediatric Air test trial

    Time frame: 5 minutes

    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

Secondary outcomes

  1. Atelectasis risk factors assessment

    Time frame: 5 minutes

    Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery

  2. Atelectasis severity

    Time frame: 5 minutes

    Determine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Collaborators

  • Hospital Privado de Comunidad
  • Hospital Universitario La Princesa

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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