Lung CollapseNCT04506203
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool
A study testing Air test in people with Lung Collapse and Lung Diseases, run by Hospital Universitario La Paz at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 5 weeks to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Collapse, Lung Diseases, Atelectasis
- What is being tested?
- Air test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Sep 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 weeks to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- General anesthesia
- Perioperative risk classification (ASA) I, II, III
- Newborns (postconceptional age> 45 weeks) to 16 years
- Need for oral / nasotracheal intubation
Who cannot join
- 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
Show all 10Show fewer
- History of untreated heart disease
- Presence or history of pneumothorax
- Presence of untreated congenital pulmonary disorders
- Refusal to participate in the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario La Princesa
Madrid
About this study
Official title: The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study
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.
Read more
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.
- Conditions
- Lung Collapse, Lung Diseases, Atelectasis, Atelectasis Without Respiratory Distress Syndrome, Atelectases, Resorption, Air Test
- Being tested
- Air test
- Keywords
- air test, atelectasis, pediatric, non-invasive, lung collapse
- Medical subject headings
- Pulmonary Atelectasis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Air test | Experimental | Not described Receives: Diagnostic Test: Air test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis incidence
Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25).
Measured: 5 minutes
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
Measured: 5 minutes
Secondary outcomes (2)
Atelectasis risk factors assessment
Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery
Measured: 5 minutes
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start10 Sep 2020
- Primary completion31 Aug 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CollapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Privado de Comunidad
- Responsible party
- Principal investigator, Patricio Gonzalez Pizarro, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506203
- Sponsor's protocol ID
- HULaPaz
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be published in a peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study
- ClinicalTrials.gov ID
- NCT04506203
- Acronym / sponsor ID
- HULaPaz
- Conditions
- Lung Collapse, Lung Diseases, Atelectasis, Atelectasis Without Respiratory Distress Syndrome, Atelectases, Resorption, Air Test
- Keywords
- air test, atelectasis, pediatric, non-invasive, lung collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Privado de Comunidad
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air test | Experimental | Diagnostic Test: Air test |
Who may qualify
- Ages
- 5 weeks to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- General anesthesia
- Perioperative risk classification (ASA) I, II, III
- Newborns (postconceptional age> 45 weeks) to 16 years
- Need for oral / nasotracheal intubation
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air testPatients will breathe 0.21 < FiO2 < 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial. | Diagnostic test | Air test |
Primary outcome
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).
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
2 secondary outcomes
Atelectasis risk factors assessment
Time frame: 5 minutes
Atelectasis severity
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Yes. IPD will be published in a peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air test in people with Lung Collapse and Lung Diseases, run by Hospital Universitario La Paz at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atelectasis incidence (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.