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Clinical Trials in China / NCT07829627
Starting soon Not applicable

Positive- vs Negative-Pressure Extubation in High-Risk Patients

NCT07829627 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2026-11-01
Last updated
2026-09-21

Condition(s) studied

Positive Pressure Extubation TechniquesNegative Pressure Extubation TechniquesHigh-risk Patients Prone to Extubation Failure

Investigational drug(s) / intervention(s)

Positive-pressure extubationNegative-pressure extubation

Positive-pressure extubation: Positive pressure technique: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.

Negative-pressure extubation: Negative pressure technique: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * General exclusion criteria: 1. Do-not-resuscitate orders 2. Preference for a specific weaning strategy by the physician in charge 3. Mental incapacity without legal representatio * Specific exclusion criteria for ultrasound: 1. Inadequate ultrasound window (subcutaneous emphysema, lung bullae, large or thick bandages, pneumothorax, etc 2. severe bleeding tendency 3. recent severe hemoptysis, dyspnea, severe cough or patient unable to cooperate. * Specific exclusion criteria for EIT: 1. pacemaker or implanted defibrillator 2. local skin infection or open wound in the chest area where the electrode band is attached to the skin 3. unstable spinal injury or fracture * Withdrawal criteria: 1. the subjects or their family requesting to withdraw informed consent 2. The trial being unable to proceed normally due to changes in the patient's own condition or personnel operations 3. During the research, patients are escalated with respiratory support using non-invasive ventilation or high-flow oxygen therapy.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality

More Shanghai Zhongshan Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07829627 on ClinicalTrials.gov ↗ ← All trials in China