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NCT Number: NCT06900426

Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 PEEP

Other

Using 10cmH2O PEEP during anesthetic induction monitored by EIT.

ZEEP

Other

No PEEP

5PEEP

Other

Using 5cmH2O PEEP

Primary outcomes

  1. the dorsal △EELV after 2 minutes anesthetic induction

    Time frame: 2 minutes after anesthetic induction

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

Secondary outcomes

  1. driving pressure

    Time frame: 2 minutes after anesthetic induction

    Pplat - PEEP

  2. GI

    Time frame: 2 minutes after anesthetic induction

    Global imhomogeneity monitored by EIT

  3. CoV

    Time frame: 2 minutes after anesthetic induction

    The central of ventilation monitored by EIT

  4. hemodynamics

    Time frame: During anesthetic induction

    Blood pressure

  5. PaO2/FiO2

    Time frame: During anesthetic induction

    PaO2/FiO2 during anesthetic induction

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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