Physiological Study of High PEEP in Noninvasive Ventilation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorChongqing Medical University

About this trial

To investigate the physiological effects of high positive end-expiratory pressure (PEEP) during noninvasive ventilation in patients with hypoxemic respiratory failure, and to elucidate the mechanisms underlying high PEEP-induced improvement in oxygenation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

PaCO₂ ≤ 50 mmHg

PaO₂/FiO₂ ≤ 300 mmHg

Use of a noninvasive ventilator with esophageal pressure monitoring capability (e.g., Mindray SV70) -

Disqualifiers

Respiratory failure caused by heart failure, asthma, or acute exacerbation of chronic obstructive pulmonary disease (COPD) (COPD as a comorbidity may be included)

Pneumothorax

Patients who refuse to participate in this trial -

Trial design

Design model

Single group

Treatments tested in this trial

  • high PEEP

    Procedure/Surgery

    First, PEEP was set at 5 cmH₂O, and inspiratory pressure was adjusted to achieve a target tidal volume of 6-8 mL/kg. Fraction of inspired oxygen (FiO₂) was titrated to maintain peripheral oxygen saturation (SpO₂) between 88% and 92%. Subsequently, PEEP was increased in 5 cmH₂O increments every 10-20 minutes from the initial value of 5 cmH₂O. Once PEEP reached 20 cmH₂O or above, increments were made every 3-5 minutes until the recruitment level was achieved (i.e., PEEP was increased stepwise from 5 to 10, 15, 20, 25, and 30 cmH₂O). Inspiratory pressure was adjusted concurrently to maintain a constant pressure difference. Throughout the procedure, physiological parameters-including respiratory rate, oxygenation, work of breathing, and others-were collected.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: High PEEP groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxygenation

The changes of SpO2/FiO2 from 5 to 30 cmH2O of PEEP.

Time frame
From enrollment to 2 hours post-intervention

Secondary outcomes

1

Respiratory rate

Changes of respiratory rate from 5 to 30 cmH2O of PEEP

Time frame
From enrollment to 2 hours post-intervention
2

Blood pressure

Changes of blood pressure from 5 to 30 cmH2O of PEEP

Time frame
From enrollment to 2 hours post-intervention
3

Heart rate

Changes of heart rate from 5 to 30 cmH2O of PEEP

Time frame
From enrollment to 2 hours post-intervention
4

Diaphragmatic excursion

Changes in diaphragmatic excursion across PEEP levels from 5 to 30 cmH₂O. Diaphragmatic excursion refers to the movement of the thoracic diaphragm during breathing, as assessed by ultrasound.

Time frame
From enrollment to 2 hours post-intervention

Other outcomes

Sponsors and contacts

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