NCT05873998

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

February 28, 2023

Last Update Submit

May 13, 2025

Conditions

Keywords

carbon dioxidemechanical ventilation

Outcome Measures

Primary Outcomes (2)

  • Airway pressure

    Airway pressure will be measured at the airways opening and expressed in cmH2O.

    30 minutes

  • Carbon dioxide

    Expired carbon dioxide will be measured at the airways opening by a main-stream capnograph, expressed in mmHg.

    30 minutes

Study Arms (1)

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.

Diagnostic Test: Slow pressure-volume curve

Interventions

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

Also known as: Lung recruitment maneuver
Adults anesthetized patients undergoing mediastinoscopy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing general anesthesia for mediastinoscopy.

You may qualify if:

  • Age \> 17 years ole
  • Programmed surgery

You may not qualify if:

  • Pregnancy
  • No programmed surgery
  • Hemodynamic instability
  • Severe COPD
  • Acute respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Nora Fuentes, PhD

    Hospital Privado de Comunidad

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

May 24, 2023

Study Start

February 28, 2023

Primary Completion

May 1, 2025

Study Completion

May 10, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations