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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05241002
Other study ID # PL-2020100X
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date April 30, 2022

Study information

Verified date October 2022
Source Fu Jen Catholic University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Tracheostomy is a utilitarian surgical procedure of access; therefore, it should be discussed in light of the problem it addresses: access to the tracheobronchial tree. The trachea is a conduit between the upper airway and the lungs that delivers moist warm air and expels carbon dioxide and sputum. Failure or blockage at any point along that conduit can be most readily corrected with the provision of access for mechanical ventilators and suction equipment. In the case of upper airway obstruction, tracheostomy provides a path of low resistance for air exchange.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date April 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patents under planning tracheostomy will enroll to this study. Exclusion Criteria: - Pregnant women, age under 18 and unable to insert nasogastric tube

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Fu Jen Catholic University Hospital, Fu Jen Catholic University New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Goligher 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. — View Citation

Kallio 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cardiopulmonary function parameters heart rate (HR) one year
Secondary Cardiopulmonary function parameters blood pressure (BP) one year
Secondary Cardiopulmonary function parameters stroke volume (SV) one year
Secondary Cardiopulmonary function parameters cardiac output (CO) one year
Secondary Cardiopulmonary function parameters total peripheral resistance (TPR) one year
See also
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