To Determine the Annual Prevalence of Airway ClosureNCT07368491
Prevalence of Airway Closure
An observational study of To Determine the Annual Prevalence of Airway Closure, run by Romina Belen Mattei at 1 site in Argentina.
Trial summary
The primary objective of this study is to describe the prevalence of airway closure during the total support phase of invasive mechanical ventilation in subjects admitted to an intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine the Annual Prevalence of Airway Closure
- What is being tested?
- airway closure
- How many people
- 75 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients undergoing mechanical ventilation within the first 72 hours following endotracheal intubation.
Who may be able to join
- Patients over 18 years of age
- Requiring invasive mechanical ventilation within 48 to 72 hours after orotracheal intubation
- Hemodynamically stable (mean arterial pressure greater than 60 mmHg and/or norepinephrine less than 0.5 mcg/kg/min)
- Without respiratory muscle effort
Who cannot join
- Neumothorax
- Bronchopleural fistula
- Clinical evidence or suspicion of elevated intracranial pressure (greater than 18 mmHg)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
CMPFA Churruca-Visca
Buenos Aires, Buenos Aires, 1437
Romina B Mattei, +54 011 40485216, rominabelenmattei@gmail.com
Maria E Dotta, +54 011 55722761, mariaeugeniadotta@gmail.com
About this study
Official title: Annual Prevalence of Airway Closure During the Full Support Phase of Invasive Mechanical Ventilation in Adults in an Intensive Care Unit
The primary objective of this study is to describe the prevalence of airway closure during the total support phase of invasive mechanical ventilation in subjects admitted to an intensive care unit (ICU). The secondary objective is to analyze whether there are clinical-demographic and/or ventilatory characteristics associated with the presence of airway closure.
Read the detailed description
Cross-sectional study. To detect airway closure, the maneuver will be performed at low flow and in case of having an opening pressure greater than 5 cmh20, the electrical impedance tomograph will be placed to record the delay in the change of impedance of each quadrant.
- Being tested
- airway closure
- Keywords
- airway closure, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway closureOther
After setting the flow at 5 L/min and positive end-expiratory pressure (PEEP) at 0 cmH2O, the respiratory rate will be transiently decreased to achieve a prolonged expiration of 5-10 seconds to eliminate auto-PEEP. During two breaths, the change in the slope of the pressure-time curve will be observed. Airway Closure be detected as a change in the slope of the pressure-time curve. Airway Opening Pressure value, in cmH2O, will be identified on the pressure-volume curve using the cursor while the mechanical ventilator screen is frozen. Upon completion of this procedure, the ventilator settings will be returned to the patient's initial parameters.
What is being measured
The primary outcome is the main question the study is designed to answer.
airway closure
After setting the flow at 5 Litres/minute and positive end-expiratory pressure (PEEP) at 0 cmH2O, the respiratory rate will be transiently decreased to achieve a prolonged expiration of 5-10 seconds to eliminate auto-PEEP. During two breaths, the change in the slope of the pressure-time curve will be observed. Airway Closure be detected as a change in the slope of the pressure-time curve. Airway Opening Pressure value, in cmH2O, will be identified on the pressure-volume curve using the cursor while the mechanical ventilator screen is frozen. Upon completion of this procedure, the ventilator settings will be returned to the patient's initial parameters.
Measured: first 72 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Annual Prevalence of Airway ClosureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Romina Belen Mattei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Romina Belen Mattei, Complejo Médico Churruca Visca
- Investigators
- Romina B Mattei, Principal investigator, CMPFA Churruca-Visca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368491
- Sponsor's protocol ID
- CEI-05092025
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annual Prevalence of Airway Closure During the Full Support Phase of Invasive Mechanical Ventilation in Adults in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07368491
- Acronym / sponsor ID
- CEI-05092025
- Keywords
- airway closure, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Romina Belen MatteiUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
The primary objective of this study is to describe the prevalence of airway closure during the total support phase of invasive mechanical ventilation in subjects admitted to an intensive care unit (ICU). The secondary objective is to analyze whether there are clinical-demographic and/or ventilatory characteristics associated with the presence of airway closure.
Detailed description
Cross-sectional study. To detect airway closure, the maneuver will be performed at low flow and in case of having an opening pressure greater than 5 cmh20, the electrical impedance tomograph will be placed to record the delay in the change of impedance of each quadrant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing mechanical ventilation within the first 72 hours following endotracheal intubation.
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Requiring invasive mechanical ventilation within 48 to 72 hours after orotracheal intubation
- Hemodynamically stable (mean arterial pressure greater than 60 mmHg and/or norepinephrine less than 0.5 mcg/kg/min)
- Without respiratory muscle effort
Key exclusion criteria (3 listed)
- Neumothorax
- Bronchopleural fistula
- Clinical evidence or suspicion of elevated intracranial pressure (greater than 18 mmHg)
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 |
|---|---|---|
| airway closureAfter setting the flow at 5 L/min and positive end-expiratory pressure (PEEP) at 0 cmH2O, the respiratory rate will be transiently decreased to achieve a prolonged expiration of 5-10 seconds to eliminate auto-PEEP. During two breaths, the change in the slope of the pressure-time curve will be observed. Airway Closure be detected as a change in the slope of the pressure-time curve. Airway Opening Pressure value, in cmH2O, will be identified on the pressure-volume curve using the cursor while the mechanical ventilator screen is frozen. Upon completion of this procedure, the ventilator settings will be returned to the patient's initial parameters. | Other | – |
Primary outcome
airway closure
Time frame: first 72 hours after intubation
After setting the flow at 5 Litres/minute and positive end-expiratory pressure (PEEP) at 0 cmH2O, the respiratory rate will be transiently decreased to achieve a prolonged expiration of 5-10 seconds to eliminate auto-PEEP. During two breaths, the change in the slope of the pressure-time curve will be observed. Airway Closure be detected as a change in the slope of the pressure-time curve. Airway Opening Pressure value, in cmH2O, will be identified on the pressure-volume curve using the cursor while the mechanical ventilator screen is frozen. Upon completion of this procedure, the ventilator settings will be returned to the patient's initial parameters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
Romina B Mattei principal investigator
CMPFA Churruca-Visca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Determine the Annual Prevalence of Airway Closure, run by Romina Belen Mattei at 1 site in Argentina.
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 3 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romina B Mattei (+541140485216, rominabelenmattei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway closure (time frame: first 72 hours after intubation). 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 13 Mar 2026.