Clinical trial NCT06900426: Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction
Official title: Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Injury, Acute
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the dorsal △EELV after 2 minutes anesthetic induction
timeFrame: 2 minutes after anesthetic induction
Secondary outcomes:
measure: driving pressure
timeFrame: 2 minutes after anesthetic induction
measure: GI
timeFrame: 2 minutes after anesthetic induction
measure: CoV
timeFrame: 2 minutes after anesthetic induction
measure: hemodynamics
timeFrame: During anesthetic induction
measure: PaO2/FiO2
timeFrame: During anesthetic induction
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Centre
state: Shanghai
Study officials:
affiliation: Fudan University Shanghai Cancer Centre
name: Jun Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: