Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction

NCT ID: NCT06900426

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-28

Study Completion Date

2025-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Anesthetic induction could lead to lung atelectasis, increase intrapulmonary shunt, and potentially impair oxygenation. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

General anesthesia may introduce lung atelectasis, which causes an increase in intrapulmonary shunt, and impairs oxygenation, even in the lung-healthy subjects. The magnitude of shunt is correlated with the formation of pulmonary atelectasis. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension. Surgical patients with healthy lungs were randomly assigned to receive 0, 5 or 10 cmH2O PEEP (PEEP0, PEEP5 and PEEP10 groups). Anesthetic induction was performed by certified registered anesthesiologists, during which the patients were mechanically ventilated using the volume-controlled mode. Electrical impedance tomography (EIT) was used to dynamically assess the lung atelectasis during anesthetic induction (spontaneous, mask, and endotracheal intubation ventilation). The primary outcome was the dorsal change of end expiratory lung impedance (â–³EELI) after 2 mins anesthetic induction. The secondary outcome was driving pressure, EIT-derived ventilation homogeneity, hemodynamics and PaO2/FiO2.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Injury, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEEP0

There is ZEEP during anesthetic induction

Group Type OTHER

ZEEP

Intervention Type OTHER

No PEEP

PEEP5

There is 5 cmH2O PEEP during anesthetic induction.

Group Type EXPERIMENTAL

5PEEP

Intervention Type OTHER

Using 5cmH2O PEEP

PEEP10

There is 10 cmH2O PEEP during anesthetic induction.

Group Type EXPERIMENTAL

10 PEEP

Intervention Type OTHER

Using 10cmH2O PEEP during anesthetic induction monitored by EIT.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10 PEEP

Using 10cmH2O PEEP during anesthetic induction monitored by EIT.

Intervention Type OTHER

ZEEP

No PEEP

Intervention Type OTHER

5PEEP

Using 5cmH2O PEEP

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* between 18 and 80 years
* scheduled for elective non-cardiothoracic cancer surgery
* general anesthesia.

Exclusion Criteria

* acute or chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD) or asthma;
* a history of lung surgery
* a high risk of reflux and aspiration
* a requirement for awake intubation
* facial or thoracic deformities
* the presence of implants, such as cardiac pacemakers
* pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jun Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jun Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University Shanghai Cancer Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fudan University Shanghai Cancer Centre

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2502-Exp148

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.