The Impact of Frailty on Adverse Events in Patients Undergoing Gastrointestinal Procedural Sedation: a Multicentre, Prospective, Observational Study(FRAEPS Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sedation Complication
- Sponsor
- Uludag University
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Advers event,fraility
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Seda Cansabuncu
Medical Doctor
Uludag University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Advers event,fraility
Time Frame: first day
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)
Secondary Outcomes
- Precedural advers event(First day)
- Capnography and side effects(First day)
- Postprocedural advers event(Third day)