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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05873998
Other study ID # CP2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 28, 2023
Est. completion date October 1, 2023

Study information

Verified date February 2023
Source Hospital Privado de Comunidad de Mar del Plata
Contact Gerardo Tusman, MD
Phone 542234990074
Email gtusman@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Age > 17 years ole - Programmed surgery Exclusion Criteria: - Pregnancy - No programmed surgery - Hemodynamic instability - Severe COPD - Acute respiratory infection

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Slow pressure-volume curve
Patients will be sequentially subjected to a slow pressure-volume curve and a lung recruitment maneuver

Locations

Country Name City State
Argentina Hospital Privado de Comunidad Mar del Plata Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Airway pressure Airway pressure will be measured at the airways opening and expressed in cmH2O. 30 minutes
Primary Carbon dioxide Expired carbon dioxide will be measured at the airways opening by a main-stream capnograph, expressed in mmHg. 30 minutes
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