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use of simple airway device to reduce Sedation Related complications during ERCP procedures

Nasopharyngeal Airway as an adjunct to reduce Sedation Related Adverse Events during ERCP procedures

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054141
Enrollment
120
Registered
2023-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Soft ,flexible, silicone Nasopharyngeal airway to supplement oxygenation during ERCP procedure.: To determine the incidence of desaturation, hypotension, arrhythmia, unplanned intubatio

Sponsors

Department of GI Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The outcome will be defined in terms of SRAEs & would include 1. Oxygen Desaturation 2. Hypotension 3. Arrhythmia 4. Moderate to severe airway obstruction requiring advanced airway manoeuvres 5. Unplanned intubation 6. Unplanned ERCP termination due to the above adverse effects Timepoint: Intra procedure

Secondary

MeasureTime frame
1. Patient satisfaction & comfort of the procedure 2. Endoscopist satisfaction regarding smoothness of the procedureTimepoint: Post procedure

Countries

India

Contacts

Public ContactDr Tapas Ghose

IPGME&R And SSKM Hospital

g.tapas@gmail.com9903745071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026