Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05829486
Other study ID # 147/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2023
Est. completion date November 5, 2023

Study information

Verified date August 2023
Source Gaziosmanpasa Research and Education Hospital
Contact sibel bektas, MD
Phone 02129453030
Email sibel-bektas@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 5, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - ASA 1-2-3 risk scored patients, - patients over the age of 18 who will undergo endoscopic intervention Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
gastroscopy
anaesthetic management of ambulatory endoscopic procedures

Locations

Country Name City State
Turkey Gaziosmanpasa TREH Istanbul Gaziosmanpasa

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 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
See also
  Status Clinical Trial Phase
Completed NCT03298776 - I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions N/A
Completed NCT02887378 - Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps N/A
Recruiting NCT01627171 - Colonoscopy Preparation Optimization for INpatients- COIN Study Phase 4
Completed NCT02350933 - Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation N/A
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT06033729 - Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA N/A
Withdrawn NCT04983498 - Enhanced Recovery Pathway for Endoscopy Phase 4
Enrolling by invitation NCT04719117 - Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
Completed NCT03369197 - Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy N/A
Completed NCT04186390 - Learning Small Bowel Capsule Endoscopy
Completed NCT02714699 - Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy Phase 2/Phase 3
Completed NCT00614159 - Ketamine Compared to Propofol for Pediatric GI Endoscopy N/A
Completed NCT04072328 - Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam Phase 2
Completed NCT04150237 - Using Simulation to Ensure Basic Competence in Gastroscopy
Completed NCT03287687 - Safety and Efficacy of CO2 for Endoscopy Phase 4
Not yet recruiting NCT03351790 - Endoscopy Quality Study N/A
Completed NCT04541667 - Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant N/A
Active, not recruiting NCT06168682 - Nasal CPAP - The Treatment IMpact on Oxygenation in High-risk Patients During Deep Sedation for Endoscopy N/A
Recruiting NCT05479253 - AI-assisted Endoscopy Report System In Improving Reporting Quality N/A
Recruiting NCT04903444 - Development and Validation of an Artificial Intelligence-based Biliary Stricture Navigation System in MRCP-based ERCP N/A