Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

Frailty Clinical Trial

Official title:

The Impact of Frailty on Adverse Events in Patients Undergoing Gastrointestinal Procedural Sedation: a Multicentre, Prospective, Observational Study(FRAEPS Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044298
• Other study ID #: 2023-16/23
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Uludag University
• Contact: seda cansabuncu, doctor
• Phone: +902242953124
• Email: sedacansabuncu[@]uludag.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators will include in our study patients aged 60 and over who have been evaluated in the pre-anesthesia clinic for procedures such as endoscopy, colonoscopy, ERCP, PEG, EUS, and ESD, and who have received sedation by an anesthesiologist. Patients will be assessed for frailty prior to the procedure; during and after the procedure, respiratory monitoring (SpO2, capnography) will be closely observed, and they will be contacted by phone three days later.

Primary goal of the study is to prospectively investigate the incidence of peri-procedural complications (desaturation, bradycardia, hypotension, etc.) in elderly patients undergoing gastrointestinal procedural sedation, and to assess its relationship with detected frailty using the FRAIL scale.Secondary goals of the study are to identify risk factors for adverse events, examine the relationship of these factors with 'ASA score - age and frailty scale', and determine their impact on the incidence of adverse events. Additionally, investigators aim to research the effects of capnography-based respiratory monitoring on adverse events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years and older patients

• ASA physical state I -IV

• Patients who are qualified to give written informed consent

• Elective gastrointestinal interventions performed under the care of the anesthesia team (such as gastroscopy, colonoscopy).

Exclusion Criteria:

• ASA IV patients

• Patients using sedative agents / Patients already sedated for other purposes

• Non-consenting patients

• Patients with any upper airway obstructive pathology or a history of difficult airway

• Emergency procedures

Related Conditions & MeSH terms

• Frailty
• Sedation Complication

Intervention

Other:
• procedural sedation
"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed."

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advers event,fraility	The primary aim of the FRAEPS study is to prospectively investigate the incidence of peri-procedural complications in elderly patients undergoing gastrointestinal procedural sedation, as well as the relationship between these complications and the frailty assessed by the FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of weight) scale. FRAIL Scale is rated from 0-5. (Non frail:0, prefrail:1-2, frail: 3-5)	first day
Secondary	Precedural advers event	The secondary objectives of the FRAEPS study are to determine risk factors for adverse events, explore the relationship between ASA (American Society of Anesthesiologist) classification and frailty scale.	First day
Secondary	Capnography and side effects	Investigators intend to investigate the effects of monitoring respiratory activity through capnography on the improvement of procedural side effects.	First day
Secondary	Postprocedural advers event	In the early post-procedural period (Day 3), investigators will assess whether the patient has returned to their pre-procedure state, whether they require additional support, and determine rates of readmission.	Third day