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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation | The changes of SpO2/FiO2 from 5 to 30 cmH2O of PEEP. | From enrollment to 2 hours post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Changes of respiratory rate from 5 to 30 cmH2O of PEEP | From enrollment to 2 hours post-intervention |
| Blood pressure | Changes of blood pressure from 5 to 30 cmH2O of PEEP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Duan | Contact | +86-89012680 | duanjun412589@163.com | |
| Yiwei Min | Contact | +8689012144 | 496996728@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Duan, MD | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16081548 | Result | 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. | |
| 27002273 | 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. |
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The informed consent form for this study clearly states that patients' data are only accessible to the research team and regulatory authorities when necessary, and shall not be disclosed to other individuals or institutions.Therefore, there is no plan to make data publicly available for this study.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| From enrollment to 2 hours post-intervention |
| Heart rate | Changes of heart rate from 5 to 30 cmH2O of PEEP | From enrollment to 2 hours post-intervention |
| 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. | From enrollment to 2 hours post-intervention |
| Diaphragm thickening fraction | 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. | From enrollment to 2 hours post-intervention |
| Work of breathing | 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. | From enrollment to 2 hours post-intervention |
| Electrical impedance tomography of the lung | 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. | From enrollment to 2 hours post-intervention |
| Tidal volume | Changes of tidal volume from 5 to 30 cmH2O of PEEP | From enrollment to 2 hours post-intervention |
| 29323536 | 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. |
| 27812731 | 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. |