- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873998
Detecting Lung's Closing Pressure by Capnography
Analysis of CO2/Volume and CO2-pressure Curves to Detect the Lung's Closing Pressure in Ventilated Patients
General anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway.
Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local inflammatory response in atelectatic lung areas known as ventilatory-induced lung injury. This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes them to hypoxemic episodes that can persist in the early postoperative period.
Lung recruitment maneuvers restore the functional residual capacity and, therefore, protect the lungs from lung injury. A key issue in this kind of treatment is detecting the lung's closing pressure in order to maintain the end-expiratory pressure above such a limit.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective and observational study designed to measure the lung's closing pressure. The investigators will study 20 mechanically ventilated patients scheduled for mediastinoscopy surgery under general anesthesia.
Lung mechanics and capnography will be assessed during surgery. A slow pressure-volume curve will be automatically performed by the ventilator, and the small airway closing pressure will be determined as the inflection point in the alveolar slope of the pressure-CO2 and volume-CO2 curves. Then, a lung recruitment maneuver will be applied following a descending positive end-expiratory pressure trial to determine the lung's closing pressure. The investigator will see if the lung's closing pressure found with these two techniques is similar.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, 7600
- Hospital Privado de Comunidad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 17 years ole
- Programmed surgery
Exclusion Criteria:
- Pregnancy
- No programmed surgery
- Hemodynamic instability
- Severe COPD
- Acute respiratory infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults anesthetized patients undergoing mediastinoscopy
Determination of the lung's closing pressure by pressure-CO2 and volume-CO2 curves using a slow pressure-volume curve after anesthesia induction.
Later on, a standard lung recruitment maneuver followed by a positive end-expiratory pressure trial was done to detect the lung's closing pressure.
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Patients will be sequentially subjected to a slow pressure-volume curve and a lung recruitment maneuver
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Airway pressure
Time Frame: 30 minutes
|
Airway pressure will be measured at the airways opening and expressed in cmH2O.
|
30 minutes
|
|
Carbon dioxide
Time Frame: 30 minutes
|
Expired carbon dioxide will be measured at the airways opening by a main-stream capnograph, expressed in mmHg.
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30 minutes
|
Collaborators and Investigators
Investigators
- Study Chair: Nora Fuentes, PhD, Hospital Privado de Comunidad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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