Physiological Study of High PEEP in Noninvasive Ventilation

NCT07503509 | Recruiting

• 1 other identifier: ChongqingMU07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure With Hypoxia

Keywords

noninvasive ventilation; PEEP; respiratory failure

Outcome Measures

Primary Outcomes (1)

• Oxygenation

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

  From enrollment to 2 hours post-intervention

Secondary Outcomes (8)

• Respiratory rate

  From enrollment to 2 hours post-intervention

• Blood pressure

  From enrollment to 2 hours post-intervention

• Heart rate

  From enrollment to 2 hours post-intervention

• Diaphragmatic excursion

  From enrollment to 2 hours post-intervention

• Diaphragm thickening fraction

  From enrollment to 2 hours post-intervention

Study Arms (1)

High PEEP group

EXPERIMENTAL

PEEP is increased stepwise from 5 cmH₂O, with increments of 5 cmH₂O every 10-20 minutes until reaching 20 cmH₂O. Once PEEP reaches or exceeds 20 cmH₂O, increments are made every 3-5 minutes until the recruitment level is achieved (i.e., stepwise increases to 5, 10, 15, 20, 25, and 30 cmH₂O). Inspiratory pressure is adjusted simultaneously to maintain a constant pressure difference.

Procedure: high PEEP

Interventions

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.

High PEEP group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (4)

• L'Her E, Deye N, Lellouche F, Taille S, Demoule A, Fraticelli A, Mancebo J, Brochard L. Physiologic effects of noninvasive ventilation during acute lung injury. Am J Respir Crit Care Med. 2005 Nov 1;172(9):1112-8. doi: 10.1164/rccm.200402-226OC. Epub 2005 Aug 4.

  PMID: 16081548 RESULT

• Yoshida T, Roldan R, Beraldo MA, Torsani V, Gomes S, De Santis RR, Costa EL, Tucci MR, Lima RG, Kavanagh BP, Amato MB. Spontaneous Effort During Mechanical Ventilation: Maximal Injury With Less Positive End-Expiratory Pressure. Crit Care Med. 2016 Aug;44(8):e678-88. doi: 10.1097/CCM.0000000000001649.

  PMID: 27002273 RESULT

• Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.

  PMID: 29323536 RESULT

• Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3.

  PMID: 27812731 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jun Duan, MD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Duan

CONTACT

+86-89012680; duanjun412589@163.com

Yiwei Min

CONTACT

+8689012144; 496996728@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 31, 2026
• Study Start: March 26, 2024
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)