Lung Diseases Clinical Trial
Official title:
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study
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 |
Verified date | August 2023 |
Source | Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Privado de Comunidad | Córdoba | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario La Princesa | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario La Paz | Hospital Privado de Comunidad, Hospital Universitario La Princesa |
Argentina, Spain,
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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