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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Do-not-resuscitate orders

Preference for a specific weaning strategy by the physician in charge

Mental incapacity without legal representatio

Inadequate ultrasound window (subcutaneous emphysema, lung bullae, large or thick bandages, pneumothorax, etc

Trial design

Design model

Parallel

Treatments tested in this trial

  • Positive-pressure extubation

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Positive-pressure extubationExperimental treatment 1 intervention
Group B: Negative-pressure extubationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.

Secondary outcomes

1

Regional Ventilation Delay (RVD) measured by Electrical Impedance Tomography (EIT)

Time frame
Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
2

Global Inhomogeneity Index (GI) measured by Electrical Impedance Tomography (EIT)

Time frame
Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
3

Center of Ventilation (COV) measured by Electrical Impedance Tomography (EIT)

Time frame
Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.
4

End-Expiratory Lung Volume (EELV) measured by Electrical Impedance Tomography (EIT)

Time frame
Baseline (before spontaneous breathing test), immediately before extubation, 30 minutes after extubation, 2 hours after extubation, and 6 hours after extubation.

Other outcomes

Sponsors and contacts

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