TracheostomyNCT05241002
The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial
An observational study of Tracheostomy, run by Fu Jen Catholic University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- How many people
- 4 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient in a single intensive care unit, under planning tracheostomy will enroll to this study.
Who may be able to join
- Patents under planning tracheostomy will enroll to this study.
Who cannot join
- Pregnant women, age under 18 and unable to insert nasogastric tube
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial: Before and After Tracheostomy
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.
Read the 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.
- Conditions
- Tracheostomy
- Keywords
- tracheostomy, diaphragm electrical impulse, diaphragm activity, endotracheal tube
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (5)
Cardiopulmonary function parameters
heart rate (HR)
Measured: one year
Cardiopulmonary function parameters
blood pressure (BP)
Measured: one year
Cardiopulmonary function parameters
stroke volume (SV)
Measured: one year
Cardiopulmonary function parameters
cardiac output (CO)
Measured: one year
Cardiopulmonary function parameters
total peripheral resistance (TPR)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Aug 2020
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Why it stopped: Difficult to recruiting due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241002
- Sponsor's protocol ID
- PL-2020100X
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23641946Kallio 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.
PubMed 25103680Goligher 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.
PubMed 28930478
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial: Before and After Tracheostomy
- ClinicalTrials.gov ID
- NCT05241002
- Acronym / sponsor ID
- PL-2020100X
- Conditions
- Tracheostomy
- Keywords
- tracheostomy, diaphragm electrical impulse, diaphragm activity, endotracheal tube
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficult to recruiting due to COVID-19 pandemic
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient in a single intensive care unit, under planning tracheostomy will enroll to this study.
Key inclusion criteria (1 listed)
- Patents under planning tracheostomy will enroll to this study.
Key exclusion criteria (1 listed)
- Pregnant women, age under 18 and unable to insert nasogastric tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The electrical activity of the diaphragm (Edi)
Time frame: one year
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
5 secondary outcomes
Cardiopulmonary function parameters
Time frame: one year
Cardiopulmonary function parameters
Time frame: one year
Cardiopulmonary function parameters
Time frame: one year
Cardiopulmonary function parameters
Time frame: one year
Cardiopulmonary function parameters
Time frame: one year
Results and safety
The study was stopped early (reason given: Difficult to recruiting due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 23641946Demoule 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.
- Background: PubMed 25103680Kallio 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.
- Background: PubMed 28930478Goligher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult to recruiting due to COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The electrical activity of the diaphragm (Edi) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241002, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.