Study Stopped
Difficult to recruiting due to COVID-19 pandemic
The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial
1 other identifier
observational
4
1 country
1
Brief Summary
The aim of this study is to investigate the use of Edi in patients under the endotracheal tube and tracheostomy, and analysis of cardiopulmonary parameters in adult patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedOctober 27, 2022
October 1, 2022
1.7 years
June 8, 2021
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The electrical activity of the diaphragm (Edi)
Edi is the primary requirement for NAVA to function and the main source for ventilator trigger. This study will find the difference of data of Edi after surgery
one year
Secondary Outcomes (5)
Cardiopulmonary function parameters
one year
Cardiopulmonary function parameters
one year
Cardiopulmonary function parameters
one year
Cardiopulmonary function parameters
one year
Cardiopulmonary function parameters
one year
Eligibility Criteria
patient in a single intensive care unit, under planning tracheostomy will enroll to this study.
You may qualify if:
- Patents under planning tracheostomy will enroll to this study.
You may not qualify if:
- Pregnant women, age under 18 and unable to insert nasogastric tube
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352, Taiwan
Related Publications (3)
Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
PMID: 23641946BACKGROUNDKallio M, Peltoniemi O, Anttila E, Jounio U, Pokka T, Kontiokari T. Electrical activity of the diaphragm during neurally adjusted ventilatory assist in pediatric patients. Pediatr Pulmonol. 2015 Sep;50(9):925-31. doi: 10.1002/ppul.23084. Epub 2014 Aug 7.
PMID: 25103680BACKGROUNDGoligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
PMID: 28930478BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Leader of Respiratory Therapist
Study Record Dates
First Submitted
June 8, 2021
First Posted
February 15, 2022
Study Start
August 1, 2020
Primary Completion
March 31, 2022
Study Completion
April 30, 2022
Last Updated
October 27, 2022
Record last verified: 2022-10