Cardiac SurgeryNCT05321173
Fast-Track in Cardiac Anesthesia
An observational study of Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The introduction of fast-track extubation procedures following cardiac surgery has significantly shortened hospitalization times in intensive care units. In this study, it was aimed to determine the obstacles to the early recovery of patients who underwent cardiac surgery in the crisis environment that developed with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 15 May 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: Adult patients who underwent elective or emergency cardiac surgery within 2 months
Who may be able to join
- All adult patients who underwent elective or emergency cardiac surgery
Who cannot join
- Patients undergoing pediatric cardiac surgeries
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital
Ankara, Select State/Province, 06800
About this study
Official title: Non-interventional Feasibility Assessment for Fast-Track Cardiac Anesthesia
The introduction of fast-track extubation procedures following cardiac surgery has significantly shortened hospitalization times in intensive care units. In this study, it was aimed to determine the obstacles to the early recovery of patients who underwent cardiac surgery in the crisis environment that developed with the pandemic.
Read the detailed description
After the time we struggled to overcome the many crises that the pandemic period brought to our lives, it has been clearly seen that the decrease in the number of nurses and doctors and the limitation of the number of beds allocated for postoperative intensive care have been mandatory attempts due to the shift of personnel to areas to fight the pandemic. The fact that cardiac surgery operations are not elective and cardiac patients cannot wait for a long time due to their existing pathologies has led physicians to strive to provide the best service with available resources. To ensure that the cardiac surgery operating room and intensive care beds of our hospital can be used more efficiently and to take initiatives to optimize the recovery in the postoperative period are among the important goals of today and the future. The reason for this is not only to reduce costs and loss of workforce but also to be ready for any crisis time. In addition, it is aimed to perform the operations of critical patients without delay and to successfully discharge them. In the postoperative period, if the functions of many basic organ systems can provide the necessary ideal conditions, the patients can be extubated within 8 hours in fast-track cardiac anesthesia (FTCA) programs. Some problems persist or occur in patients with functional problems such as hemodynamics, cardiac, and respiration who do not meet the extubation criteria. For all these reasons, a prospective, cross-sectional study was planned to focus on daily standard practices and improve areas of failure.
Accordingly, this study aimed to examine the preoperative, intraoperative, and postoperative characteristics of patients who underwent cardiac surgery, and to investigate the factors in patients who could not be extubated within 8 hours after surgery.
- Conditions
- Cardiac Surgery
- Keywords
- cardiac anesthesia, fast-track, pandemic, ICU, early recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extubation ≤ 8 hour | Patients who mechanically ventilated less than 8 hours postoperatively | |
| Extubation > 8 hour | Patients who mechanically ventilated more than 8 hours postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
Mechanical ventilation duration postoperatively
Measured: Postoperative period, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Apr 2022
- Study completion15 May 2022
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 Cardiac SurgeryStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Balcı, Ankara City Hospital Bilkent
- Investigators
- ZELİHA A DEMİR, Professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321173
- Sponsor's protocol ID
- MH2.6
- Status last verified
- May 2022
- First submitted
- 23 Mar 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haanschoten MC, van Straten AH, ter Woorst JF, Stepaniak PS, van der Meer AD, van Zundert AA, Soliman Hamad MA. Fast-track practice in cardiac surgery: results and predictors of outcome. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):989-94. doi: 10.1093/icvts/ivs393. Epub 2012 Sep 5.
PubMed 22951954Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
PubMed 27616189Myles PS, Daly DJ, Djaiani G, Lee A, Cheng DC. A systematic review of the safety and effectiveness of fast-track cardiac anesthesia. Anesthesiology. 2003 Oct;99(4):982-7. doi: 10.1097/00000542-200310000-00035. No abstract available.
PubMed 14508335
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Feasibility Assessment for Fast-Track Cardiac Anesthesia
- ClinicalTrials.gov ID
- NCT05321173
- Acronym / sponsor ID
- MH2.6
- Conditions
- Cardiac Surgery
- Keywords
- cardiac anesthesia, fast-track, pandemic, ICU, early recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 11 Apr 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 introduction of fast-track extubation procedures following cardiac surgery has significantly shortened hospitalization times in intensive care units. In this study, it was aimed to determine the obstacles to the early recovery of patients who underwent cardiac surgery in the crisis environment that developed with the pandemic.
Detailed description
After the time we struggled to overcome the many crises that the pandemic period brought to our lives, it has been clearly seen that the decrease in the number of nurses and doctors and the limitation of the number of beds allocated for postoperative intensive care have been mandatory attempts due to the shift of personnel to areas to fight the pandemic. The fact that cardiac surgery operations are not elective and cardiac patients cannot wait for a long time due to their existing pathologies has led physicians to strive to provide the best service with available resources. To ensure that the cardiac surgery operating room and intensive care beds of our hospital can be used more efficiently and to take initiatives to optimize the recovery in the postoperative period are among the important goals of today and the future. The reason for this is not only to reduce costs and loss of workforce but also to be ready for any crisis time. In addition, it is aimed to perform the operations of critical patients without delay and to successfully discharge them. In the postoperative period, if the functions of many basic organ systems can provide the necessary ideal conditions, the patients can be extubated within 8 hours in fast-track cardiac anesthesia (FTCA) programs. Some problems persist or occur in patients with functional problems such as hemodynamics, cardiac, and respiration who do not meet the extubation criteria. For all these reasons, a prospective, cross-sectional study was planned to focus on daily standard practices and improve areas of failure.
Accordingly, this study aimed to examine the preoperative, intraoperative, and postoperative characteristics of patients who underwent cardiac surgery, and to investigate the factors in patients who could not be extubated within 8 hours after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation ≤ 8 hour | – | –Patients who mechanically ventilated less than 8 hours postoperatively |
| Extubation > 8 hour | – | –Patients who mechanically ventilated more than 8 hours postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent elective or emergency cardiac surgery within 2 months
Key inclusion criteria (1 listed)
- All adult patients who underwent elective or emergency cardiac surgery
Key exclusion criteria (1 listed)
- Patients undergoing pediatric cardiac surgeries
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
Extubation time
Time frame: Postoperative period, up to 24 hours
Mechanical ventilation duration postoperatively
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 24 May 2022.
- Results publication: PubMed 22951954Haanschoten MC, van Straten AH, ter Woorst JF, Stepaniak PS, van der Meer AD, van Zundert AA, Soliman Hamad MA. Fast-track practice in cardiac surgery: results and predictors of outcome. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):989-94. doi: 10.1093/icvts/ivs393. Epub 2012 Sep 5.
- Results publication: PubMed 27616189Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
- Results publication: PubMed 14508335Myles PS, Daly DJ, Djaiani G, Lee A, Cheng DC. A systematic review of the safety and effectiveness of fast-track cardiac anesthesia. Anesthesiology. 2003 Oct;99(4):982-7. doi: 10.1097/00000542-200310000-00035. No abstract available.
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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.
ZELİHA A DEMİR, Professor principal investigator
Ankara City Hospital Bilkent
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 Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 24 May 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 Turkey (Türkiye). 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?
Extubation time (time frame: Postoperative period, up to 24 hours). 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 NCT05321173, 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 24 May 2022.