Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction

NCT06900426 | Completed DMC

• 1 other identifier: 2502-Exp148
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Injury, Acute

Outcome Measures

Primary Outcomes (1)

• the dorsal △EELV after 2 minutes anesthetic induction

  The primary outcome was the dorsal △EELV after 2 minutes anesthetic induction (endotracheal intubation ventilation) monitored by EIT.

  2 minutes after anesthetic induction

Secondary Outcomes (5)

• driving pressure

  2 minutes after anesthetic induction

• GI

  2 minutes after anesthetic induction

• CoV

  2 minutes after anesthetic induction

• hemodynamics

  During anesthetic induction

• PaO2/FiO2

  During anesthetic induction

Study Arms (3)

PEEP0

OTHER

There is ZEEP during anesthetic induction

Other: ZEEP

PEEP5

EXPERIMENTAL

There is 5 cmH2O PEEP during anesthetic induction.

Other: 5PEEP

PEEP10

EXPERIMENTAL

There is 10 cmH2O PEEP during anesthetic induction.

Other: 10 PEEP

Interventions

10 PEEP OTHER

Using 10cmH2O PEEP during anesthetic induction monitored by EIT.

PEEP10

ZEEP OTHER

No PEEP

PEEP0

5PEEP OTHER

Using 5cmH2O PEEP

PEEP5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jun Zhang, Professor

  Fudan University Shanghai Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 28, 2025
• Study Start: March 28, 2025
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date：The study was officially published. End date：Two years after the study was officially published.
• Access Criteria: The data sets are available from the corresponding author through email on reasonable request by reletive investigators.

Locations

CN (1)