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临床试验/NCT07358039
NCT07358039
招募中
不适用

Impact of a Recruitment Maneuver After Closed Endotracheal Suctioning on End-expiratory Lung Volume in Mechanically Ventilated ICU Patients Assessed by Electrical Impedance Tomography

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年4月2日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
入组人数
32
试验地点
1
主要终点
Percentage change in end-expiratory lung volume (EELV) after suctioning

概览

简要总结

Patients who are intubated and mechanically ventilated in the intensive care unit (ICU) require repeated endotracheal suctioning to remove airway secretions. Although this procedure is necessary, it can cause a temporary collapse of lung units (alveolar derecruitment), leading to a decrease in lung volume and impaired oxygenation.

A recruitment maneuver consists of briefly applying a higher airway pressure after suctioning in order to reopen collapsed lung areas and restore lung volume. However, the clinical benefit of performing a recruitment maneuver systematically after suctioning remains uncertain.

This study aims to evaluate whether performing a recruitment maneuver immediately after closed-circuit endotracheal suctioning improves lung volume compared with suctioning alone. Lung volume will be assessed using electrical impedance tomography (EIT), a non-invasive bedside imaging technique that allows real-time monitoring of lung aeration.

In a randomized crossover design, each patient will undergo two suctioning procedures: one followed by a recruitment maneuver and one without, in a random order. The main outcome will be the change in end-expiratory lung volume 15 minutes after suctioning. The results may help optimize ventilatory care in mechanically ventilated ICU patients.

详细描述

Endotracheal suctioning in mechanically ventilated ICU patients is a common procedure but is associated with alveolar derecruitment, resulting in a decrease in end-expiratory lung volume (EELV), deterioration of oxygenation, and potential lung injury.

A recruitment maneuver applied immediately after suctioning may reopen collapsed alveoli and restore lung volume, provided that sufficient positive end-expiratory pressure is maintained. However, available data are limited and conflicting, especially in adult ICU patients.

This prospective, randomized, open-label, single-center crossover trial will evaluate the physiological impact of a recruitment maneuver performed after closed-circuit endotracheal suctioning.

Each patient will receive two interventions in random order:

  • Treatment A: closed-circuit endotracheal suctioning alone
  • Treatment B: closed-circuit endotracheal suctioning followed immediately by a recruitment maneuver (airway pressure 30 cmH₂O for 30 seconds, with unchanged PEEP) Patients will be randomized to one of two sequences (AB or BA), with a 15-minute washout period between interventions.

Electrical impedance tomography (PulmoVista® V500) will be used to measure end-expiratory lung impedance, which reflects EELV. Functional residual capacity will be measured using nitrogen washout on a CARESCAPE R860 ventilator. Lung compliance and PaO₂/FiO₂ ratio will also be recorded.

Measurements will be obtained before suctioning and 15 minutes after each intervention. The primary endpoint is the percentage change in EELV at 15 minutes after suctioning between the two conditions.

A total of 32 mechanically ventilated ICU patients will be included.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥18 years
  • Covered by national health insurance
  • Admitted to the intensive care unit
  • Intubated and mechanically ventilated
  • Neuromuscular blockade at inclusion
  • Written informed consent obtained from a legally authorized representative or next of kin

排除标准

  • Contraindication to electrical impedance tomography (e.g. pacemaker, implantable cardioverter-defibrillator, or implanted electrical stimulation device)
  • Contraindication to recruitment maneuvers (e.g. emphysema, undrained pneumothorax, hemodynamic instability)
  • Refractory intracranial hypertension
  • Acute respiratory distress syndrome requiring prone positioning
  • Pregnant or breastfeeding women
  • Patients deprived of liberty or under legal protection
  • Any condition judged by the investigator to interfere with study evaluation

研究组 & 干预措施

A

Experimental

Patients undergo closed-circuit endotracheal suctioning without a recruitment maneuver.

干预措施: Closed-circuit endotracheal suctioning (Procedure)

B

Experimental

Patients undergo closed-circuit endotracheal suctioning immediately followed by a recruitment maneuver.

干预措施: Suction + Recruitment maneuver (Procedure)

结局指标

主要结局

Percentage change in end-expiratory lung volume (EELV) after suctioning

时间窗: 15 minutes after endotracheal suctioning

EELV assessed by end-expiratory lung impedance measured with electrical impedance tomography (PulmoVista® V500).

次要结局

  • Change in lung compliance(Baseline and 15 minutes after suctioning)
  • Change in functional residual capacity (FRC)(Baseline and 15 minutes after suctioning)
  • Change in PaO₂/FiO₂ ratio(Baseline and 15 minutes after suctioning)

研究者

发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
申办方类型
Other
责任方
Sponsor

研究点 (1)

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