Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With ARDS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Chao Yang Hospital

About this trial

To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective mechanical ventilation strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

ARDS caused by pneumonia (New Global Definition of ARDS)

PaO2/FiO2≤200mmHg

Received invasive mechanical ventilation

Disqualifiers

Invasive mechanical ventilation duration > 48 hours

History of pulmonary hypertension caused by various reasons

Severe arrhythmia

BMI>30kg/m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transpulmonary pressure guided mechanical ventilation strategy

    Device

    Tidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O. In control group, PEEP was titrated using the low PEEP:FiO₂ table method.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Transpulmonary pressure groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of right ventricular involvement within 28 days

Right ventricular involvement is defined as the presence of one of the following findings on transthoracic echocardiography: ACP: Right ventricular enlargement (RVED/LVED \> 0.6) with paradoxical septal motion; RVF: Right ventricular enlargement (RVED/LVED \> 0.6) accompanied by systemic venous congestion (CVP ≥ 8 mmHg), or if CVP is unavailable, inferior vena cava plethora; RVD: RV FAC \< 35%, or TAPSE ≤ 16 mm.

Time frame
28 days

Secondary outcomes

1

The respective incidence rates of ACP, RVF and RVD

Time frame
28 days
2

ICU mortality

Time frame
28 days and 60 days
3

invasive mechanical ventilation duration

Time frame
28 days
4

the number of participants receiving vasoactive agents

Time frame
28 days

Other outcomes

Sponsors and contacts

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