Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
Study NCT ID:
NCT04506203
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool
Sponsor:
Hospital Universitario La Paz
Organization:
Study Overview
Official Title:
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: