Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction

Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction: a Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Lung Injury, Acute
• Intervention / Treatment: Other: ZEEP; Other: 5PEEP; Other: 10 PEEP

Detailed Description

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 (△EELI) after 2 mins anesthetic induction. The secondary outcome was driving pressure, EIT-derived ventilation homogeneity, hemodynamics and PaO2/FiO2.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PEEP0; There is ZEEP during anesthetic induction	Other: ZEEP; No PEEP
Experimental: PEEP5; There is 5 cmH2O PEEP during anesthetic induction.	Other: 5PEEP; Using 5cmH2O PEEP
Experimental: PEEP10; There is 10 cmH2O PEEP during anesthetic induction.	Other: 10 PEEP; Using 10cmH2O PEEP during anesthetic induction monitored by EIT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
driving pressure	Pplat - PEEP	2 minutes after anesthetic induction
GI	Global imhomogeneity monitored by EIT	2 minutes after anesthetic induction
CoV	The central of ventilation monitored by EIT	2 minutes after anesthetic induction
hemodynamics	Blood pressure	During anesthetic induction
PaO2/FiO2	PaO2/FiO2 during anesthetic induction	During anesthetic induction

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jun Zhang, Professor, Fudan University Shanghai Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 22, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Pulmonary Atelectasis; Lung Injury; Acute Lung Injury
• Other Study ID Numbers: 2502-Exp148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: Start date：The study was officially published. End date：Two years after the study was officially published.
• IPD Sharing Access Criteria: The data sets are available from the corresponding author through email on reasonable request by reletive investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No