Integrated Pulmonary Index in Gastroscopic Procedures

Recruiting

• Conditions: Endoscopy
• Interventions: Procedure: gastroscopy

• Registration Number: NCT05829486
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief 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.

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 Timeline

• Study Start: 2023-02-06
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
remiprop	gastroscopy	At the beginning of anesthesia, 1 mcg/kg of remifentanil and 0.75 mg/kg propofol will be administered.
ketaprop	gastroscopy	At the beginning of anesthesia, 0.25 mg/kg ketamine and 0.75 mg/kg propofol will be administered.

Primary Outcome Measures

Name	Time	Method
respiratory complications comparing different sedative groups	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)

Trial Locations

Locations (1)

Gaziosmanpaşa TREH; 🇹🇷 Istanbul, Gaziosmanpaşa, Turkey