Clinical trial NCT05241002: The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial
Official title: The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial: Before and After Tracheostomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tracheostomy
Keywords: tracheostomy
diaphragm electrical impulse
diaphragm activity
endotracheal tube
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient in a single intensive care unit, under planning tracheostomy will enroll to this study.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patents under planning tracheostomy will enroll to this study.

Exclusion Criteria:

* Pregnant women, age under 18 and unable to insert nasogastric tube

Primary outcomes:
measure: The electrical activity of the diaphragm (Edi)
timeFrame: one year
Secondary outcomes:
measure: Cardiopulmonary function parameters
timeFrame: one year
measure: Cardiopulmonary function parameters
timeFrame: one year
measure: Cardiopulmonary function parameters
timeFrame: one year
measure: Cardiopulmonary function parameters
timeFrame: one year
measure: Cardiopulmonary function parameters
timeFrame: one year
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
References:
citation: 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.
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.
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.