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临床试验/NCT07829627
NCT07829627尚未招募不适用

A Comparison of the Physiological Effects of Positive Pressure and Negative Pressure Techniques on High-risk Patients With Extubation Failure: a Single-center Randomized Controlled Study

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年11月1日最近更新:
适应症
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
96
试验地点
1
主要终点
The primary outcome is percentage of ROI3 and ROI4 measured by EIT monitoring

研究概览

简要总结

In the intensive care unit (ICU), weaning from mechanical ventilation and extubation are critical clinical goals. Successful extubation not only significantly shortens mechanical ventilation duration but also reduces the incidence of complications such as ventilator-associated pneumonia. However, extubation failure rates remain high, especially in high-risk patient populations. Even after passing the Spontaneous Breathing Trial (SBT), 10%-25% of high-risk patients experience respiratory deterioration post-extubation, necessitating reintubation. Therefore, optimizing extubation strategies for high-risk patients is essential.

Currently, extubation techniques in clinical practice are primarily classified into negative pressure extubation and positive pressure extubation. Traditional negative pressure extubation involves continuous tracheal suction to clear secretions; however, this negative pressure can lead to alveolar collapse, regional ventilation mismatch, and an increased risk of aspiration. In contrast, positive pressure extubation maintains airway pressure (such as pressure support or positive end expiratory pressure), which theoretically facilitates the movement of subglottic secretions toward the oropharynx, while also promoting alveolar recruitment and improving ventilation/perfusion matching. Although randomized controlled trials have explored the safety of these two techniques, the conclusions remain controversial. Some studies suggest that positive pressure extubation reduces post-extubation hypoxemia and reintubation rates, while a meta-analysis indicates no statistically significant difference in overall complication rates between the two methods. This discrepancy may arise from heterogeneity in study populations, inadequate standardization of operational parameters, and the limited sensitivity of traditional monitoring methods in detecting regional pulmonary dynamic changes.

In recent years, Electrical Impedance Tomography (EIT) and Lung Ultrasound (LUS) have emerged as non-invasive bedside monitoring technologies, offering new insights into the physiological effects of extubation. EIT enables real-time dynamic imaging to quantitatively map both whole-lung and regional ventilation distributions, allowing for the sensitive detection of alveolar collapse or over-expansion. LUS, utilizing its B-line scoring system, provides an objective assessment of lung ventilation loss with high sensitivity and specificity. The combined use of these two techniques not only reveals the effects of extubation on overall oxygenation but also facilitates a detailed analysis of regional ventilation heterogeneity and compensatory mechanisms, thereby offering multimodal data to optimize extubation strategies.

This study proposes the design of a single-center, prospective, randomized controlled trial to systematically assess the physiological differences between positive pressure and negative pressure extubation techniques in high-risk patients prone to extubation failure. The goal is to provide evidence-based support for developing individualized extubation strategies tailored to high-risk patients.

详细描述

Patients meeting at least one of the criteria for increased risk of extubation failure: be over 65 years of age or have any underlying chronic cardiac or pulmonary disease. Underlying chronic cardiac disease includes left ventricular dysfunction (left ventricular ejection fraction equal to or less than 45%); history of cardiogenic pulmonary edema; ischemic heart disease or persistent atrial fibrillation; underlying chronic lung disease including chronic obstructive pulmonary disease, obesity-hypopnea syndrome, or restrictive lung disease.

Patients meeting weaning criteria: resolution or improvement of the pathology that motivated intubation, clinical stability (heart rate (HR) < 140 bpm, systolic blood pressure (BP) 90-160 mmHg without vasopressors or at minimum doses); pass the spontaneous breathing trail (SBT): The ventilator was in pressure support mode, with a pressure support of 8 cmH20 and a positive end-expiratory pressure of 5 cmH20 for 30 min. SBT success criteria: respiratory rate/tidal volume ratio <105, respiratory rate >8 times/min or <35 times/min, spontaneous tidal volume >4 mL/kg, arterial oxygen saturation >0.90, arterial blood gas analysis pH value >7.35, Pa02/Fi02 >150 mmHg; adequate mentation (no sedation or adequate mentation on sedation, Glasgow Coma Scale (GCS) > 13) Electrical impedance tomography (EIT) is a noninvasive bedside imaging technique that allows real-time assessment of global and regional lung ventilation. It provides dynamic information on changes in tidal volume distribution and lung aeration, which may help to better understand the physiological effects of different extubation techniques.

This single-center randomized controlled study aims to compare the physiological effects of positive-pressure and negative-pressure extubation in adult patients at high risk of extubation failure. Patients will be randomly assigned to one of the two extubation techniques. Lung ventilation will be assessed using EIT before and after extubation. Extubation-related complications and changes in oxygenation parameters will also be recorded. The results of this study are expected to provide evidence to guide the selection of extubation techniques in high-risk patients.

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
Double (Care Provider, Outcomes Assessor)

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

  • Patients aged ≥ 18 years undergoing MV for ≥ 24 h
  • Patients meeting at least one of the criteria for increased risk of extubation failure
  • Patients meeting weaning criteria
  • Patients or their families agree to participate in this trial and sign an informed consent form

排除标准

  • General exclusion criteria:
  • Do-not-resuscitate orders
  • Preference for a specific weaning strategy by the physician in charge
  • Mental incapacity without legal representatio
  • Specific exclusion criteria for ultrasound:
  • Inadequate ultrasound window (subcutaneous emphysema, lung bullae, large or thick bandages, pneumothorax, etc
  • severe bleeding tendency
  • recent severe hemoptysis, dyspnea, severe cough or patient unable to cooperate.
  • Specific exclusion criteria for EIT:
  • pacemaker or implanted defibrillator
  • local skin infection or open wound in the chest area where the electrode band is attached to the skin
  • unstable spinal injury or fracture
  • Withdrawal criteria:
  • the subjects or their family requesting to withdraw informed consent
  • The trial being unable to proceed normally due to changes in the patient's own condition or personnel operations
  • During the research, patients are escalated with respiratory support using non-invasive ventilation or high-flow oxygen therapy.

研究组 & 干预措施

Positive-pressure extubation

Experimental

the ventilator will be not disconnected. In the original SBT mode, the patient will be instructed to inhale forcefully. When the patient reached the peak inspiratory flow rate, the cuff will be deflated and the endotracheal tube will be removed without endotracheal suction. Once the endotracheal tube is removed, a suction tube is used to aspirate oropharyngeal secretions.

干预措施: Positive-pressure extubation (Procedure)

Negative-pressure extubation

Experimental

disconnect the ventilator, insert the suction tube into the endotracheal tube and pass it over the distal opening, perform continuous negative pressure suction in the trachea, and at the same time evacuate the cuff of the endotracheal tube, and remove the suction tube and the catheter together.

干预措施: Negative-pressure extubation (Procedure)

结局指标

主要结局

The primary outcome is percentage of ROI3 and ROI4 measured by EIT monitoring

时间窗: Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.

次要结局

  • Regional Ventilation Delay (RVD) measured by Electrical Impedance Tomography (EIT)(Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.)
  • Global Inhomogeneity Index (GI) measured by Electrical Impedance Tomography (EIT)(Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.)
  • Center of Ventilation (COV) measured by Electrical Impedance Tomography (EIT)(Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.)
  • End-Expiratory Lung Volume (EELV) measured by Electrical Impedance Tomography (EIT)(Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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