The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics

Официальное название

The Impact of Low Versus High Positive End-Expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics During Pressure Support Ventilation: A Randomized Interventional Crossover Study

Обзор

The goal of this interventional study is to evaluate the effect of different positive end-expiratory pressures (PEEP) on lung and diaphragm function in patients mechanically ventilated with pressure support ventilation in the intensive care unit. The main questions aim to answer: Does higher PEEP level affect diaphragm contractions and ventilatory efficiency? Does higher PEEP level limit inspiratory efforts? Does higher PEEP level affect lung compliance? The participants will be subjected to three different PEEP levels during pressure support ventilation: Low PEEP (4 cmH2O), Medium PEEP (10 cmH2O), High PEEP (16 cmH2O). The lung and diaphragm function will be evaluated using high-resolution esophageal manometry, electrical activity of the diaphragm, external diaphragm ultrasound and spirometric ventilator data.

Вмешательства

• Процедура Low positive end-expiratory pressure
  Low (4 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.
• Процедура Medium positive end-expiratory pressure
  Medium (10 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.
• Процедура High positive end-expiratory pressure
  High(16 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.

Первичные конечные точки

• Inspiratory effort [Срок оценки: Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level]
• Inspiratory drive [Срок оценки: Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level]
• Effort-to-drive ratio [Срок оценки: Calculated from the measures collected 10 minutes after application of interventional PEEP level]
• Neuromechanical efficiency [Срок оценки: Calculated from the measures collected during the occlusion manoeuvre performed 10-15 minutes after application of interventional PEEP level]
• Thickening fraction of the diaphragm (TFdi) [Срок оценки: Measured 10 minutes after application of interventional PEEP level]
• Transpulmonary driving pressure [Срок оценки: Measured during 5 breaths 10 minutes after application of interventional PEEP level]
• Occlusion pressure [Срок оценки: The occlusion pressure will be measured during an occlusion manoeuvre performed 10-15 minutes after application of interventional PEEP level.]

Вторичные конечные точки (5)

• Airway driving pressure [Срок оценки: Measured during an inspiratory hold performed 10-15 minutes after application of interventional PEEP level]
• Lung compliance [Срок оценки: Measured during an inspiratory hold performed 10 - 15 minutes after application of interventional PEEP level]
• Thickening fraction of the expiratory abdominal muscles (TFabd) [Срок оценки: Measured 10 minutes after application of interventional PEEP level]
• Oxygenation [Срок оценки: The blood gas will be collected 10 minutes after application of interventional PEEP level]
• Respiratory system compliance [Срок оценки: Measured during an inspiratory hold manoeuvre performed 10-15 minutes after the application of interventional PEEP level.]

Критерии участия

Критерии включения

• Mechanical ventilation with pressure support or mechanical ventilation with possibility to transition to pressure support
• Oxygen requirement ≤ 50%
• Pressure support ≤ 12 cmH2O
• PEEP ≤ 12 cmH2O
• Age ≥ 18 years
• Adequate intravascular volume status

Критерии исключения

• Circulatory instability
• Brain death diagnosis/brain death evaluation
• Norepinephrine dose > 0.4 µg/kg/min
• Muscle relaxation administered within 2 hours
• Pregnancy
• Contraindication to esophageal catheterization (e.g., esophageal varices)
• Conditions with increased risk of pneumothorax (such as severe COPD (Chronic Obstructive Pulmonary Disease) or extensive emphysema)
• Untreated pneumothorax
• Symptomatic airway obstruction

Discontinuation criteria during ongoing study intervention:

• Heart rate > 120 beats/min
• Systolic blood pressure > 180 mmHg
• Inspired oxygen fraction > 70%
• Respiratory rate > 35/min
• RASS (Richmond Agitation Sedation Scale) ≥ 2
• Doubling of norepinephrine dose or increase of norepinephrine dose to > 0.5 µg/kg/min to maintain mean arterial pressure
• Bradycardia < 45 beats/min

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Швеция · 2 центра

• Central intensivvårdsavdelning, Sahlgrenska University Hospital — Gothenburg
• Thorax intensivvårdsavdelning, Område 6, Sahlgrenska University Hospital, Västra Götalands — Gothenburg

Идентификаторы

NCT: NCT07188038 · 2025-01286-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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