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Not yet recruiting NCT07638176

Effect of Individualized Positive End-expiratory Pressure (PEEP) in Patients Who Have an Intrinsic PEEP During One-lung Ventilation

No phase Interventional Pulmonary Disease (COPD), Chronic Obstructive Lung Resection Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEEP0, PEEP5, PEEPi.
Who it may be relevant to
Registry conditions: Pulmonary Disease (COPD), Chronic Obstructive, Lung Resection Surgery. Basic parameters: 19 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Individualized Positive End-expiratory Pressure (PEEP) on Intrinsic PEEP and Stroke Volume During One-lung Ventilation: a Single-center, Randomized Crossover Study

Overview

This study investigates the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability in patients with intrinsic PEEP undergoing lung resection surgery, using a randomized, crossover design.

Detailed description

Intrinsic positive end-expiratory pressure (iPEEP) frequently occurs during one-lung ventilation (OLV), which is essential for lung resection. This occurrence is driven by three primary factors. First, a significant portion of patients undergoing lung surgery have concomitant chronic obstructive pulmonary disease (COPD) and thus possess a baseline intrinsic PEEP. Second, high-frequency ventilation applied to prevent carbon dioxide accumulation during OLV shortens the expiratory time, thereby generating intrinsic PEEP. Third, the use of a narrow-bore double-lumen endobronchial tube for OLV increases airway resistance, accelerating the development of intrinsic PEEP. Intrinsic PEEP causes lung hyperinflation and elevates intrathoracic pressure, which can subsequently decrease venous return and lead to abrupt hypotension. However, research remains insufficient regarding the optimal level of extrinsic PEEP for patients who develop intrinsic PEEP during OLV. While an extrinsic PEEP of around 5 cmH2O is generally applied during OLV, some guidelines recommend completely removing extrinsic PEEP (0 cmH2O) during OLV in COPD patients. Nevertheless, this recommendation lacks robust scientific evidence. Furthermore, whether the strategy of setting extrinsic PEEP at approximately 70% of intrinsic PEEP-as suggested by studies in critically ill patients-is equally valid in the intraoperative OLV environment remains unverified. Theoretically, if extrinsic PEEP exceeds intrinsic PEEP, it may exacerbate lung hyperinflation by increasing expiratory resistance. Conversely, an extrinsic PEEP that is too low may cause airway collapse during expiration, paradoxically worsening gas trapping. Therefore, this study aims to evaluate the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability using a randomized, crossover design.

Interventions

  • Procedure PEEP0
    PEEP 0 (zero) means off-PEEP on the anesthesia machine.
  • Procedure PEEP5
    PEEP5 means setting the PEEP to 5 cmH2O on the anesthesia machine.
  • Procedure PEEPi
    PEEPi (individualized PEEP) means setting the PEEP to 70% of intrinsic PEEP on the anesthesia machine.

Primary outcome measures

  • Intrinsic positive end-expiratory airway pressure [Time frame: During a 30-minute period from the start of one-lung ventilation to the completion of the intervention]
  • Stroke volume [Time frame: During a 30-minute period from the start of one-lung ventilation to the completion of the intervention]

Eligibility criteria

Inclusion criteria

  • American Society of Anesthesiologists Physical Status I - III
  • The Eastern Cooperative Oncology Group Performance Status Grade 0 - 2
  • Lung resection surgery requiring one-lung ventilation for over 60 minutes
  • Indication of double-lumen endobronchial tube (female 35 Fr, male 37 Fr)
  • Patient who is diagnosed with intrinsic PEEP during one-lung ventilation

Exclusion criteria

  • Large bullae
  • Emergency surgery
  • Mechanical ventilation before surgery
  • Hemodynamic instability before surgery
  • Surgery requiring cardiopulmonary bypass
  • Pregnancy, breastfeeding patient
  • Patient's refusal to participate
  • No intrinsic PEEP during one-lung ventilation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07638176 · Individual PEEP trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗