ERASNCT05617768
Enhanced Recovery After Surgery (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire
An observational study of ERAS, run by Cairo University at 1 site in Egypt.
Trial summary
ERAS after cardiac surgery is a well known protocol ,However the investigators study if it is applied at our institute Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- ERAS
- How many people
- 267 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2022to 1 Nov 2023
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Anesthesia department, Cairo university hospitals, kasr al-ainy. * Cardiothoracic thoracic surgery department, Cairo university hospitals, kasr al-ainy. * Anesthesia department, National Heart Institute. * Cardiothoracic surgery department, National Heart Institute.
Who may be able to join
- Cardiac anesthesiologists.
- Cardiac intensivists.
- Cardiothoracic surgeons.
- All stuff members from resident to consultant are included inside this study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unviersity
Cairo
Sherif M Abbas, MD, 0201141235049, s25041989@hotmail.com
About this study
Official title: Enhanced Recovery After Surgey (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire
ERAS after cardiac surgery is a well known protocol ,However the investigators study if it is applied at our institute
Read the detailed description
Enhanced recovery after surgery (ERAS) is a term that include a series of evidence-based perioperative care pathways designed to reduce physiological and psychological stress in surgical patients and to achieve rapid recovery.
In 2016, the first pilot study was published, which analyzed enhanced recovery after cardiac surgery (ERACS). Weaning from mechanical ventilation is considered one of the items that forms the concept of enhanced recovery in cardiac surgery.
Pain is an undesirable consequence of surgery especially cardiac surgery as pain during and following cardiac surgery has been shown to be a risk factor for increased morbidity. Systemic opioids have been the main stay for the management of perioperative pain in cardiac surgery. Lower doses of opioids has been related to early extubation and minimizing opioid-related side effects, such as prolonged ventilation, tolerance, nausea, vomiting, gut dysfunction, and immunosuppression.
On the other hand the investigators find cases of morbidity and mortality not related to the surgical procedure. ERAS protocol discuss the optimum condition that can be used to avoid the morbidity and mortality complications.
the investigators aim to know how well ERAS protocol is known and applied
- Conditions
- ERAS
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 |
|---|---|---|
| • Cardiac anesthesiologists • Cardiac intensivists • Cardiothoracic surgeons | * Anesthesia department, Cairo university hospitals, kasr al-ainy. * Cardiothoracic thoracic surgery department, Cairo university hospitals, kasr al-ainy. * Anesthesia department, National Heart Institute. * Cardiothoracic surgery department, National Heart Institute. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the grading system.
Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the grading system.Grading system will be described as:-
- Grade A ( knows well( : more than 60 % correct answer
- Grade B ( fair ): 35 :60 % correct answer
- Grade C ( knows nothing ) :- less than 35 % correct answer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start20 Nov 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sherif Mamdouh Abbas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617768
- Sponsor's protocol ID
- MS-337-2022
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgey (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire
- ClinicalTrials.gov ID
- NCT05617768
- Acronym / sponsor ID
- MS-337-2022
- Conditions
- ERAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 15 Nov 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.
ERAS after cardiac surgery is a well known protocol ,However the investigators study if it is applied at our institute
Detailed description
Enhanced recovery after surgery (ERAS) is a term that include a series of evidence-based perioperative care pathways designed to reduce physiological and psychological stress in surgical patients and to achieve rapid recovery.
In 2016, the first pilot study was published, which analyzed enhanced recovery after cardiac surgery (ERACS). Weaning from mechanical ventilation is considered one of the items that forms the concept of enhanced recovery in cardiac surgery.
Pain is an undesirable consequence of surgery especially cardiac surgery as pain during and following cardiac surgery has been shown to be a risk factor for increased morbidity. Systemic opioids have been the main stay for the management of perioperative pain in cardiac surgery. Lower doses of opioids has been related to early extubation and minimizing opioid-related side effects, such as prolonged ventilation, tolerance, nausea, vomiting, gut dysfunction, and immunosuppression.
On the other hand the investigators find cases of morbidity and mortality not related to the surgical procedure. ERAS protocol discuss the optimum condition that can be used to avoid the morbidity and mortality complications.
the investigators aim to know how well ERAS protocol is known and applied
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Cardiac anesthesiologists • Cardiac intensivists • Cardiothoracic surgeons | – | –* Anesthesia department, Cairo university hospitals, kasr al-ainy. * Cardiothoracic thoracic surgery department, Cairo university hospitals, kasr al-ainy. * Anesthesia department, National Heart Institute. * Cardiothoracic surgery department, National Heart Institute. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Anesthesia department, Cairo university hospitals, kasr al-ainy. * Cardiothoracic thoracic surgery department, Cairo university hospitals, kasr al-ainy. * Anesthesia department, National Heart Institute. * Cardiothoracic surgery department, National Heart Institute.
Key inclusion criteria (4 listed)
- Cardiac anesthesiologists.
- Cardiac intensivists.
- Cardiothoracic surgeons.
- All stuff members from resident to consultant are included inside this study
Key exclusion criteria (1 listed)
- -
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
Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the grading system.
Time frame: 6 months
Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the grading system.Grading system will be described as:- * Grade A ( knows well( : more than 60 % correct answer * Grade B ( fair ): 35 :60 % correct answer * Grade C ( knows nothing ) :- less than 35 % correct answer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
Related trials for ERAS
Recruiting
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
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.
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 ERAS, run by Cairo University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sherif M Abbas, MD. (0201141235049, s25041989@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the grading system. (time frame: 6 months). 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 30 Aug 2023.