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NCT Number: NCT07503509

Physiological Study of High PEEP in Noninvasive Ventilation

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.

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Key information

Conditions

Respiratory Failure With Hypoxia Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Jun Duan

CONTACT

[email protected]

86-023-89012680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • PaCO₂ ≤ 50 mmHg
  • PaO₂/FiO₂ ≤ 300 mmHg
  • Use of a noninvasive ventilator with esophageal pressure monitoring capability (e.g., Mindray SV70) -

Exclusion criteria

  • 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 -

Treatment and study plan

High PEEP

Procedure

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.

Primary outcomes

  1. Oxygenation

    Time frame: From enrollment to 2 hours post-intervention

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

Secondary outcomes

  1. Respiratory rate

    Time frame: From enrollment to 2 hours post-intervention

    Changes of respiratory rate from 5 to 30 cmH2O of PEEP

  2. Blood pressure

    Time frame: From enrollment to 2 hours post-intervention

    Changes of blood pressure from 5 to 30 cmH2O of PEEP

  3. Heart rate

    Time frame: From enrollment to 2 hours post-intervention

    Changes of heart rate from 5 to 30 cmH2O of PEEP

  4. Diaphragmatic excursion

    Time frame: From enrollment to 2 hours post-intervention

    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.

  5. Diaphragm thickening fraction

    Time frame: From enrollment to 2 hours post-intervention

    Changes in diaphragm thickening fraction across PEEP levels from 5 to 30 cmH₂O. Diaphragm thickening fraction is calculated based on the change in diaphragm thickness from end-expiration to end-inspiration ([end-inspiration - end-expiration]/end-expiration), as assessed by ultrasound.

  6. Work of breathing

    Time frame: From enrollment to 2 hours post-intervention

    Changes in work of breathing across PEEP levels ranging from 5 to 30 cmH₂O were assessed by monitoring esophageal pressure with an esophageal balloon catheter.

  7. Electrical impedance tomography of the lung

    Time frame: From enrollment to 2 hours post-intervention

    Changes in lung electrical impedance tomography were recorded across PEEP levels ranging from 5 to 30 cmH₂O. The electrical impedance tomography belt was placed around the chest at the level of the 4th to 5th intercostal spaces, and data were collected after the patient's breathing had stabilized.

  8. Tidal volume

    Time frame: From enrollment to 2 hours post-intervention

    Changes of tidal volume from 5 to 30 cmH2O of PEEP

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Duan

CONTACT

[email protected]

+86-89012680

Yiwei Min

CONTACT

[email protected]

+8689012144

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

A Physiological Study of High PEEP During Noninvasive Ventilation in Patients With Hypoxemic Respiratory Failure

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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