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

Primary Purpose

Lung Collapse, Lung Diseases, Atelectasis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Air test
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Collapse focused on measuring air test, atelectasis, pediatric, non-invasive, lung collapse

Eligibility Criteria

5 Weeks - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Privado de Comunidad
  • Hospital Universitario La Paz
  • Hospital Universitario La Princesa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Air test

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2020
Last Updated
August 7, 2023
Sponsor
Hospital Universitario La Paz
Collaborators
Hospital Universitario La Princesa, Hospital Privado de Comunidad
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1. Study Identification

Unique Protocol Identification Number
NCT04506203
Brief Title
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool
Official Title
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz
Collaborators
Hospital Universitario La Princesa, Hospital Privado de Comunidad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Validate "air test" as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Collapse, Lung Diseases, Atelectasis, Atelectasis Without Respiratory Distress Syndrome, Atelectases, Resorption, Air Test, Pediatric Disorder
Keywords
air test, atelectasis, pediatric, non-invasive, lung collapse

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Lung Collapse will be diagnosed by a blind researcher that does not know the air test results
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air test
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Air test
Intervention Description
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 Outcome Measure Information:
Title
Atelectasis incidence
Description
Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25).
Time Frame
5 minutes
Title
Accuracy of Pediatric Air test trial
Description
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
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Atelectasis risk factors assessment
Description
Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery
Time Frame
5 minutes
Title
Atelectasis severity
Description
Determine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Weeks
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Privado de Comunidad
City
Córdoba
Country
Argentina
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be published in a peer reviewed journal
IPD Sharing Time Frame
Upon publishment in journal

Learn more about this trial

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

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