Mechanical VentilationNCT05038111
Medical Records Investigation of Whether Perioperative Dexmedetomidine Will Reduce the Duration of Mechanical Ventilation or Hospital Length of Stay in Patients Undergoing Minimally Invasive Cardiac Surgery
An observational study of Mechanical Ventilation and Hospital Length of Stay, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The concept of enhanced recovery after surgery (ERAS) is utilizing in multiple specialties widely. Early tracheal extubation is one of the components of ERAS that enhances postoperative recovery and reduces the length of stay in intensive care unit (ICU).Dexmedetomidine is a highly selective, shorter-acting… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Mechanical Ventilation, Hospital Length of Stay, Minimally Invasive Cardiac Surgery
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2021to 25 Mar 2021
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were eligible for inclusion if they had undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020. Additionally patients were included if they were aged 20 years or older and were excluded if it was emergency surgery, if they had postoperative mechanical ventilation more than 6 hours or if they were extubated in the operating room.
Who may be able to join
- Patients undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020.
- Age above 20 y/o
Who cannot join
- Emergency surgery
- Postoperative mechanical ventilation more than 6 hours
- Extubated in the operating room
Trial locations and contacts
1 site in 1 country.
About this study
The concept of enhanced recovery after surgery (ERAS) is utilizing in multiple specialties widely. Early tracheal extubation is one of the components of ERAS that enhances postoperative recovery and reduces the length of stay in intensive care unit (ICU).Dexmedetomidine is a highly selective, shorter-acting α2-adrenergic receptor agonist that has both analgesic and sedativeeffects.It was associated with decreased mortality, time to extubation, and hospital length of stay in cardiac surgical patients according to previous studies.The purpose of this study was to investigate the effect of perioperative dexmedetomidine on patients undergoing minimally invasive cardiac surgery(MICS) who were early extubated after surgery.
- Being tested
- Dexmedetomidine
- Keywords
- mechanical ventilation, hospital length of stay, dexmedetomidine, Minimally Invasive Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
perioperative dexmedetomidine infusion
| Study group | Role | What they receive |
|---|---|---|
| Dex | Dexmedetomidine infusion during the perioperative period Receives: Drug: Dexmedetomidine | |
| Non-Dex | Did not have dexmedetomidine infusion during the perioperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative mechanical ventilation duration
from the time the patient arrived at the ICU until extubation
Measured: up to 1 week
ICU and hospital length of stay
Measured: through admission, up to 1 month
Secondary outcomes (1)
postoperative complications
atrial fibrillation, bradyarrhythmia, myocardial infarction, cerebrovascular accident, acute renal failure and delirium
Measured: according to ICD 10 on medical record, daily to discharge, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start11 Mar 2021
- Primary completion22 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung-Hua Yang, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038111
- Sponsor's protocol ID
- 110006-F
- Status last verified
- Mar 2021
- First submitted
- 26 Aug 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Records Investigation of Whether Perioperative Dexmedetomidine Will Reduce the Duration of Mechanical Ventilation or Hospital Length of Stay in Patients Undergoing Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05038111
- Acronym / sponsor ID
- 110006-F
- Keywords
- mechanical ventilation, hospital length of stay, dexmedetomidine, Minimally Invasive Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 8 Sep 2021 (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 concept of enhanced recovery after surgery (ERAS) is utilizing in multiple specialties widely. Early tracheal extubation is one of the components of ERAS that enhances postoperative recovery and reduces the length of stay in intensive care unit (ICU).Dexmedetomidine is a highly selective, shorter-acting α2-adrenergic receptor agonist that has both analgesic and sedativeeffects.It was associated with decreased mortality, time to extubation, and hospital length of stay in cardiac surgical patients according to previous studies.The purpose of this study was to investigate the effect of perioperative dexmedetomidine on patients undergoing minimally invasive cardiac surgery(MICS) who were early extubated after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex | – | Drug: DexmedetomidineDexmedetomidine infusion during the perioperative period |
| Non-Dex | – | –Did not have dexmedetomidine infusion during the perioperative period |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were eligible for inclusion if they had undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020. Additionally patients were included if they were aged 20 years or older and were excluded if it was emergency surgery, if they had postoperative mechanical ventilation more than 6 hours or if they were extubated in the operating room.
Key inclusion criteria (2 listed)
- Patients undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020.
- Age above 20 y/o
Key exclusion criteria (3 listed)
- Emergency surgery
- Postoperative mechanical ventilation more than 6 hours
- Extubated in the operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidineperioperative dexmedetomidine infusion | Drug | Dex |
Primary outcome
postoperative mechanical ventilation duration
Time frame: up to 1 week
from the time the patient arrived at the ICU until extubation
ICU and hospital length of stay
Time frame: through admission, up to 1 month
1 secondary outcome
postoperative complications
Time frame: according to ICD 10 on medical record, daily to discharge, up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Tsung-Hua Yang, MD principal investigator
Far Eastern Memorial Hospital
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 Mechanical Ventilation and Hospital Length of Stay, run by Far Eastern Memorial Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative mechanical ventilation duration (time frame: up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2021.