- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368491
Prevalence of Airway Closure
March 11, 2026 updated by: Romina Belen Mattei
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Romina B Mattei
- Phone Number: +541140485216
- Email: rominabelenmattei@gmail.com
Study Contact Backup
- Name: Maria E Dotta
- Phone Number: +5455722761
- Email: mariaeugeniadotta@gmail.com
Study Locations
-
-
Buenos Aires
-
Buenos Aires, Buenos Aires, Argentina, 1437
- Recruiting
- CMPFA Churruca-Visca
-
Contact:
- Romina B Mattei
- Phone Number: +54 011 40485216
- Email: rominabelenmattei@gmail.com
-
Contact:
- Maria E Dotta
- Phone Number: +54 011 55722761
- Email: mariaeugeniadotta@gmail.com
-
Sub-Investigator:
- Norberto Tiribelli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population consists of adult patients undergoing mechanical ventilation within the first 72 hours following endotracheal intubation.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Neumothorax
- Bronchopleural fistula
- Clinical evidence or suspicion of elevated intracranial pressure (greater than 18 mmHg)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
first 72 hours after intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Romina B Mattei, CMPFA Churruca-Visca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
January 12, 2026
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CEI-05092025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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