The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial

Tracheostomy Clinical Trial

Official title:

The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial: Before and After Tracheostomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05241002
• Other study ID #: PL-2020100X
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Tracheostomy

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