search
Back to results

Early PP Monitored by EIT in Patients With ARDS

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EIT-guided mechanical ventilation strategy
Lung protective ventilation group
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring acute respiratory distress syndrome, prone position, electrical impedance tomography, mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years old; Meets the diagnostic criteria for ARDS according to the 2012 Berlin definition; Intubation with invasive mechanical ventilation time < 36 hours; PaO2/FiO2 < 150mmHg. Exclusion Criteria: Contraindication to the prone position; Contraindication to the EIT; Patients have received extracorporeal membrane oxygenation treatment.

Sites / Locations

  • Beijing Chao-Yang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EIT guided group

Lung protective ventilation group

Arm Description

During prone ventilation, the PEEP level is adjusted based on EIT monitoring.

Lung-protective ventilation strategy during prone positioning that continues the supine position.

Outcomes

Primary Outcome Measures

28-day weaning rate from invasive mechanical ventilation
After weaning from invasive mechanical ventilation lasting more than 48 hours, continuation with either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV).

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
July 10, 2023
Sponsor
Beijing Chao Yang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05822869
Brief Title
Early PP Monitored by EIT in Patients With ARDS
Official Title
Early Prone Positioning Monitored by Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute Respiratory Distress Syndrome (ARDS) is a syndrome characterized by respiratory distress and refractory hypoxemia caused by pulmonary and extra-pulmonary factors. Despite improvements in diagnosis and treatment in recent years, the mortality rate of severe ARDS is still around 40%. The distribution of lung lesions in ARDS patients is significantly gravity-dependent. Even with lung-protective ventilation strategies, tidal volume is concentrated in the ventral lung region, leading to ventilator-associated lung injury. Prone position ventilation can increase ventilation to the dorsal lung tissue and improve the ventilation-perfusion ratio, thus improving oxygenation. During prone position ventilation in ARDS patients, lung-protective ventilation strategies should be maintained, but with different respiratory mechanics from the supine position, requiring adjustment of ventilator parameters. Electrical Impedance Tomography (EIT) technology can be used for bedside monitoring of mechanically ventilated patients, providing real-time feedback on the patient's ventilation status and having great potential for clinical applications. Investigators believes that EIT monitoring during prone position ventilation in ARDS patients can individualize lung-protective ventilation strategies, minimize alveolar overdistension and collapse, improve the weaning success rate of invasive ventilation, and ultimately improve patient prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
acute respiratory distress syndrome, prone position, electrical impedance tomography, mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EIT guided group
Arm Type
Experimental
Arm Description
During prone ventilation, the PEEP level is adjusted based on EIT monitoring.
Arm Title
Lung protective ventilation group
Arm Type
Other
Arm Description
Lung-protective ventilation strategy during prone positioning that continues the supine position.
Intervention Type
Procedure
Intervention Name(s)
EIT-guided mechanical ventilation strategy
Intervention Description
During prone ventilation, the PEEP level is adjusted based on EIT monitoring. The optimal PEEP is the lowest sum of collapse and overdistension percentages
Intervention Type
Procedure
Intervention Name(s)
Lung protective ventilation group
Intervention Description
Lung-protective ventilation strategy during prone positioning that continues the supine position.
Primary Outcome Measure Information:
Title
28-day weaning rate from invasive mechanical ventilation
Description
After weaning from invasive mechanical ventilation lasting more than 48 hours, continuation with either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV).
Time Frame
At 28 days of hospitalization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old; Meets the diagnostic criteria for ARDS according to the 2012 Berlin definition; Intubation with invasive mechanical ventilation time < 36 hours; PaO2/FiO2 < 150mmHg. Exclusion Criteria: Contraindication to the prone position; Contraindication to the EIT; Patients have received extracorporeal membrane oxygenation treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhao, Dr.
Phone
+8618601342030
Email
xuanben1985@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Wang, Dr.
Organizational Affiliation
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Wang, MD
Phone
+8618601342030
Email
xuanben1985@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26903337
Citation
Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
Results Reference
background
PubMed Identifier
32109013
Citation
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Results Reference
background
PubMed Identifier
10793162
Citation
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
Results Reference
background
PubMed Identifier
15269312
Citation
Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327-36. doi: 10.1056/NEJMoa032193.
Results Reference
background
PubMed Identifier
28204859
Citation
Borges JB, Hansen T, Larsson A, Hedenstierna G. The "normal" ventilated airspaces suffer the most damaging effects of mechanical ventilation. Intensive Care Med. 2017 Jul;43(7):1057-1058. doi: 10.1007/s00134-017-4708-1. Epub 2017 Feb 15. No abstract available.
Results Reference
background
PubMed Identifier
25746507
Citation
Borges JB, Costa EL, Bergquist M, Lucchetta L, Widstrom C, Maripuu E, Suarez-Sipmann F, Larsson A, Amato MB, Hedenstierna G. Lung inflammation persists after 27 hours of protective Acute Respiratory Distress Syndrome Network Strategy and is concentrated in the nondependent lung. Crit Care Med. 2015 May;43(5):e123-32. doi: 10.1097/CCM.0000000000000926.
Results Reference
background
PubMed Identifier
17038660
Citation
Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
Results Reference
background
PubMed Identifier
27400909
Citation
Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
Results Reference
background
PubMed Identifier
18427774
Citation
Fernandez R, Trenchs X, Klamburg J, Castedo J, Serrano JM, Besso G, Tirapu JP, Santos A, Mas A, Parraga M, Jubert P, Frutos F, Anon JM, Garcia M, Rodriguez F, Yebenes JC, Lopez MJ. Prone positioning in acute respiratory distress syndrome: a multicenter randomized clinical trial. Intensive Care Med. 2008 Aug;34(8):1487-91. doi: 10.1007/s00134-008-1119-3. Epub 2008 Apr 22.
Results Reference
background
PubMed Identifier
19903918
Citation
Taccone P, Pesenti A, Latini R, Polli F, Vagginelli F, Mietto C, Caspani L, Raimondi F, Bordone G, Iapichino G, Mancebo J, Guerin C, Ayzac L, Blanch L, Fumagalli R, Tognoni G, Gattinoni L; Prone-Supine II Study Group. Prone positioning in patients with moderate and severe acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2009 Nov 11;302(18):1977-84. doi: 10.1001/jama.2009.1614.
Results Reference
background

Learn more about this trial

Early PP Monitored by EIT in Patients With ARDS

We'll reach out to this number within 24 hrs