use of simple airway device to reduce Sedation Related complications during ERCP procedures
Phase 3
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/06/054141
- Lead Sponsor
- Department of GI Anaesthesiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. All ASA I and II patients and without major comorbidities undergoing therapeutic ERCP procedure under moderate to deep sedation .
2. Patients who have given written, informed consent to participate in the study.
Exclusion Criteria
1. ASA I and IV patients
2. History of nasal bleed and coagulopathy
3. Cranio facial anomalies
4. Head and face trauma
5. Deviated Nasal Septum or external nasal pathology
6. Major systemic comorbidities
7. Very sick patients
8. Morbid obesity
9. Airway difficulty
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The outcome will be defined in terms of SRAEs & would include <br/ ><br>1. Oxygen Desaturation <br/ ><br>2. Hypotension <br/ ><br>3. Arrhythmia <br/ ><br>4. Moderate to severe airway obstruction requiring advanced airway manoeuvres <br/ ><br>5. Unplanned intubation <br/ ><br>6. Unplanned ERCP termination due to the above adverse effects <br/ ><br>Timepoint: Intra procedure <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Patient satisfaction & comfort of the procedure <br/ ><br>2. Endoscopist satisfaction regarding smoothness of the procedureTimepoint: Post procedure