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Physiological Study of High PEEP in Noninvasive Ventilation

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07503509
Enrollment
50
Registered
2026-03-31
Start date
2024-03-26
Completion date
2026-06-30
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure With Hypoxia

Keywords

noninvasive ventilation, PEEP, respiratory failure

Brief summary

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.

Interventions

PROCEDUREhigh PEEP

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.

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years 2. PaCO₂ ≤ 50 mmHg 3. PaO₂/FiO₂ ≤ 300 mmHg 4. Use of a noninvasive ventilator with esophageal pressure monitoring capability (e.g., Mindray SV70) -

Exclusion criteria

1. Respiratory failure caused by heart failure, asthma, or acute exacerbation of chronic obstructive pulmonary disease (COPD) (COPD as a comorbidity may be included) 2. Pneumothorax 3. Patients who refuse to participate in this trial -

Design outcomes

Primary

MeasureTime frameDescription
OxygenationFrom enrollment to 2 hours post-interventionThe changes of SpO2/FiO2 from 5 to 30 cmH2O of PEEP.

Secondary

MeasureTime frameDescription
Respiratory rateFrom enrollment to 2 hours post-interventionChanges of respiratory rate from 5 to 30 cmH2O of PEEP
Blood pressureFrom enrollment to 2 hours post-interventionChanges of blood pressure from 5 to 30 cmH2O of PEEP
Heart rateFrom enrollment to 2 hours post-interventionChanges of heart rate from 5 to 30 cmH2O of PEEP
Diaphragmatic excursionFrom enrollment to 2 hours post-interventionChanges 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.
Diaphragm thickening fractionFrom enrollment to 2 hours post-interventionChanges 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.
Work of breathingFrom enrollment to 2 hours post-interventionChanges in work of breathing across PEEP levels ranging from 5 to 30 cmH₂O were assessed by monitoring esophageal pressure with an esophageal balloon catheter.
Electrical impedance tomography of the lungFrom enrollment to 2 hours post-interventionChanges 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.
Tidal volumeFrom enrollment to 2 hours post-interventionChanges of tidal volume from 5 to 30 cmH2O of PEEP

Countries

China

Contacts

CONTACTJun Duan
duanjun412589@163.com+86-89012680
CONTACTYiwei Min
496996728@qq.com+8689012144
PRINCIPAL_INVESTIGATORJun Duan, MD

First Affiliated Hospital of Chongqing Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026