Recruiting NCT07503509
Physiological Study of High PEEP in Noninvasive Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high PEEP.
- Who it may be relevant to
- Registry conditions: Respiratory Failure With Hypoxia. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Physiological Study of High PEEP During Noninvasive Ventilation in Patients With Hypoxemic Respiratory Failure
Overview
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
- Procedure high 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
Primary outcome measures
- Oxygenation [Time frame: From enrollment to 2 hours post-intervention]
Secondary outcome measures (8)
- Respiratory rate [Time frame: From enrollment to 2 hours post-intervention]
- Blood pressure [Time frame: From enrollment to 2 hours post-intervention]
- Heart rate [Time frame: From enrollment to 2 hours post-intervention]
- Diaphragmatic excursion [Time frame: From enrollment to 2 hours post-intervention]
- Diaphragm thickening fraction [Time frame: From enrollment to 2 hours post-intervention]
- Work of breathing [Time frame: From enrollment to 2 hours post-intervention]
- Electrical impedance tomography of the lung [Time frame: From enrollment to 2 hours post-intervention]
- Tidal volume [Time frame: From enrollment to 2 hours post-intervention]
Eligibility criteria
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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
China · 1 center
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07503509 · ChongqingMU07