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临床试验/NCT07442708
NCT07442708尚未招募不适用

Segmental Lung Recruitment: a Randomized Controlled Trial

Clinical Hospital Center Rijeka0 个研究点目标入组 20 人开始时间: 2026年2月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
Safety profile

研究概览

简要总结

This study compares two ways of reopening collapsed parts of the lung in patients on a ventilator.

In one group, doctors use a small camera (bronchoscope) to guide air pressure directly to the blocked part of the lung. In the other group, increased air pressure is applied to the whole lung using the ventilator.

Patients are carefully monitored to ensure safety.

详细描述

This study will compare two lung recruitment strategies in mechanically ventilated patients with segmental atelectasis.

In the experimental group, patients will undergo bronchoscopy-guided targeted segmental recruitment using endobronchial bloker. A flexible bronchoscope will be introduced through the endotracheal tube and advanced under direct visualization to the affected lung segment. The endobronchial blocker will be positioned to temporarily block the segmental bronchus, creating a closed system. Sustained positive pressure of 30 cmH₂O will be applied directly to the atelectatic segment for 30 minutes, while standard ventilator settings will be maintained for the remainder of the lung. Continuous monitoring of oxygen saturation, heart rate, blood pressure, and end-tidal carbon dioxide will be maintained. The maneuver will be immediately discontinued if oxygen saturation decreases by more than 10%, systolic blood pressure decreases by more than 20%, or heart rate changes by more than 20% from baseline values.

In the control group, patients will receive a conventional whole-lung recruitment maneuver. Continuous positive airway pressure (CPAP) of 40 cmH₂O will be applied to the entire respiratory system for 40 seconds using the ventilator. Monitoring and safety criteria will be identical to those used in the experimental group, and the maneuver will be discontinued if predefined thresholds are exceeded.

All patients will receive lung-protective mechanical ventilation according to current guidelines. Tidal volumes will be maintained at 6-8 mL/kg predicted body weight, plateau pressures will be limited to less than 30 cmH₂O, and positive end-expiratory pressure (PEEP) will be adjusted according to FiO₂-PEEP tables. Permissive hypercapnia will be accepted provided arterial pH remains above 7.20.

The primary outcomes will focus on safety and will include the incidence of clinically significant desaturation (oxygen saturation decrease greater than 5% from baseline) and hemodynamic instability (systolic blood pressure decrease greater than 20 mmHg or need for vasopressor dose escalation) during and within 30 minutes after the maneuver.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • treatment in ICU, presence of radiologically or clinically confirmed pulmonary atelectasis during ICU treatment, requirement for mechanical ventilation

排除标准

  • primary or secondary lung malignancy

研究组 & 干预措施

Segmental lung recruitment

Experimental

Patients will undergo bronchoscopy-guided targeted segmental lung recruitment via endobronchial blocker. Flexible bronchoscope will be introduced through the endotracheal tube and advanced under direct visualization to the affected lung segment. The endobronchial blocker will be positioned to temporarily occlude the segmental bronchus, creating a closed system. Sustained positive pressure of 30 cmH₂O will be applied directly to the atelectatic segment for 30 minutes, while standard ventilator settings will be maintained for the remaining lung tissue.

干预措施: Segmental lung recruitment (Procedure)

Control group

Active Comparator

Patients in the control group will receive standard recruitment maneuvers using continuous positive airway pressure applied for a short, sustained period at a level consistent with conventional clinical practice. This approach will reflect the commonly used recruitment strategy in routine care.

干预措施: Conventional lung recruitment (Procedure)

结局指标

主要结局

Safety profile

时间窗: From enrollment 72 hours

The primary safety outcomes will be the incidence of clinically significant desaturation and hemodynamic instability during and within 30 minutes following the recruitment.

次要结局

未报告次要终点

研究者

发起方
Clinical Hospital Center Rijeka
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matej Bura

MD

Clinical Hospital Center Rijeka

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