Integrated Pulmonary Index in Gastroscopic Procedures

Endoscopy Clinical Trial

Official title:

The Effects of Ketamine and Propofol and Remifentanil and Propofol Combinations on Integrated Pulmonary Index During Sedation in Gastroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829486
• Other study ID #: 147/22
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Endoscopy

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