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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04506203
Other study ID # HULaPaz
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2020
Est. completion date May 31, 2022

Study information

Verified date August 2023
Source Hospital Universitario La Paz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date May 31, 2022
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Weeks to 16 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Argentina Hospital Privado de Comunidad Córdoba
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario La Princesa Madrid

Sponsors (3)

Lead Sponsor Collaborator
Hospital Universitario La Paz Hospital Privado de Comunidad, Hospital Universitario La Princesa

Countries where clinical trial is conducted

Argentina,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Atelectasis incidence Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25). 5 minutes
Primary 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 5 minutes
Secondary Atelectasis risk factors assessment Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery 5 minutes
Secondary 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 5 minutes
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