EndoscopyNCT05829486
Integrated Pulmonary Index in Gastroscopic Procedures
An observational study of Endoscopy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Various complications are the leading cause of morbidity in sedation practices in endoscopic procedures, and guidelines recommend continuous monitoring of circulation, respiratory function, and ventilation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Endoscopy
- What is being tested?
- gastroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2023to 5 Nov 2023
- How long will I take part?
- 4 Months
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: over the age of 18 who will undergo endoscopic intervention
Who may be able to join
- ASA 1-2-3 risk scored patients,
- patients over the age of 18 who will undergo endoscopic intervention
Who cannot join
- Patients who need mechanical ventilator support,
- patients who need emergency endoscopic intervention,
- patients with a history of substance abuse,
- patients with a history of allergy to the drugs to be used,
- pregnant women will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
sibel bektaş, prof.MD, sibel-bektas@yahoo.com
About this study
Official title: The Effects of Ketamine and Propofol and Remifentanil and Propofol Combinations on Integrated Pulmonary Index During Sedation in Gastroscopy
Various complications are the leading cause of morbidity in sedation practices in endoscopic procedures, and guidelines recommend continuous monitoring of circulation, respiratory function, and ventilation. Integrated Pulmonary Index (IPI), one of the methods that can be used in this monitoring, gives a single numerical value obtained by continuous and simultaneous joint mathematical analysis of Oxygen saturation, End-tidal carbon dioxide concentration, respiratory rate, and heart rate values and is a good monitorization in these interventions. and provides tracking. In this study, the aim is to determine the role of IPI in the diagnosis and follow-up of respiratory complications in patients who were sedated during gastroscopy procedures.
Read the detailed description
IPI EtCO2 is a monitoring method consisting of respiratory rate, SPO2 and heart rate parameters. While EtCO2 is measured with nasal capnography, SPO2, heart rate, respiratory rate are measured with finger probe and it will show instant measurement of respiratory status. IPI takes values between 1-10. An IPI value of 8 and above will indicate normal values, a value between 5-7 will indicate that the respiratory status of the patient should be carefully examined and intervened if necessary, values of 4 and below will definitely indicate that the patient's respiratory status should be intervened.
Blood pressure measurement will be made with a sphingmomanometer noninvasively at certain time intervals with the help of a cuff that will be placed on the patient's arm area.
- Conditions
- Endoscopy
- Being tested
- gastroscopy
- Keywords
- sedation, respiratory complications, ambulatory anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroscopyProcedure or surgery
anaesthetic management of ambulatory endoscopic procedures
| Study group | Role | What they receive |
|---|---|---|
| ketaprop | At the beginning of anesthesia, 0.25 mg/kg ketamine and 0.75 mg/kg propofol will be administered. Receives: Procedure: gastroscopy | |
| remiprop | At the beginning of anesthesia, 1 mcg/kg of remifentanil and 0.75 mg/kg propofol will be administered. Receives: Procedure: gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory complications comparing different sedative groups
Comparison of sedation safety and efficacy of Ketamine and Propofol and Remifentanil and Propofol administration to be applied to patients in endoscopy by using integrated pulmonary index (1-10)
Measured: Measurements will be in 4 time frames; before induction anesthesia, 5 minutes after the induction of sedation, 10 minutes after the induction, 5 minutes after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start6 Feb 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion5 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies 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
- 60 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zuhal Çavuş, Gaziosmanpasa Research and Education Hospital
- Investigators
- zuhal çavuş, MD, Principal investigator, gaziosmanpasa TREHdöndü genç moralar, MD, Study director, gaziosmanpasa TREH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829486
- Sponsor's protocol ID
- 147/22
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ketamine and Propofol and Remifentanil and Propofol Combinations on Integrated Pulmonary Index During Sedation in Gastroscopy
- ClinicalTrials.gov ID
- NCT05829486
- Acronym / sponsor ID
- 147/22
- Conditions
- Endoscopy
- Keywords
- sedation, respiratory complications, ambulatory anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 5 Nov 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
Various complications are the leading cause of morbidity in sedation practices in endoscopic procedures, and guidelines recommend continuous monitoring of circulation, respiratory function, and ventilation. Integrated Pulmonary Index (IPI), one of the methods that can be used in this monitoring, gives a single numerical value obtained by continuous and simultaneous joint mathematical analysis of Oxygen saturation, End-tidal carbon dioxide concentration, respiratory rate, and heart rate values and is a good monitorization in these interventions. and provides tracking. In this study, the aim is to determine the role of IPI in the diagnosis and follow-up of respiratory complications in patients who were sedated during gastroscopy procedures.
Detailed description
IPI EtCO2 is a monitoring method consisting of respiratory rate, SPO2 and heart rate parameters. While EtCO2 is measured with nasal capnography, SPO2, heart rate, respiratory rate are measured with finger probe and it will show instant measurement of respiratory status. IPI takes values between 1-10. An IPI value of 8 and above will indicate normal values, a value between 5-7 will indicate that the respiratory status of the patient should be carefully examined and intervened if necessary, values of 4 and below will definitely indicate that the patient's respiratory status should be intervened.
Blood pressure measurement will be made with a sphingmomanometer noninvasively at certain time intervals with the help of a cuff that will be placed on the patient's arm area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketaprop | – | Procedure: gastroscopyAt the beginning of anesthesia, 0.25 mg/kg ketamine and 0.75 mg/kg propofol will be administered. |
| remiprop | – | Procedure: gastroscopyAt the beginning of anesthesia, 1 mcg/kg of remifentanil and 0.75 mg/kg propofol will be administered. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- over the age of 18 who will undergo endoscopic intervention
Key inclusion criteria (2 listed)
- ASA 1-2-3 risk scored patients,
- patients over the age of 18 who will undergo endoscopic intervention
Key exclusion criteria (5 listed)
- Patients who need mechanical ventilator support,
- patients who need emergency endoscopic intervention,
- patients with a history of substance abuse,
- patients with a history of allergy to the drugs to be used,
- pregnant women will be excluded from the study.
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 |
|---|---|---|
| gastroscopyanaesthetic management of ambulatory endoscopic procedures | Procedure or surgery | ketaprop, remiprop |
Primary outcome
respiratory complications comparing different sedative groups
Time frame: Measurements will be in 4 time frames; before induction anesthesia, 5 minutes after the induction of sedation, 10 minutes after the induction, 5 minutes after the end of the procedure
Comparison of sedation safety and efficacy of Ketamine and Propofol and Remifentanil and Propofol administration to be applied to patients in endoscopy by using integrated pulmonary index (1-10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
zuhal çavuş, MD principal investigator
gaziosmanpasa TREH
döndü genç moralar, MD study director
gaziosmanpasa TREH
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 Endoscopy, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 5 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 22 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sibel bektas, MD (02129453030, sibel-bektas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory complications comparing different sedative groups (time frame: Measurements will be in 4 time frames; before induction anesthesia, 5 minutes after the induction of sedation, 10 minutes after the induction, 5 minutes after the end of the procedure). 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 22 Aug 2023.