Hypoxemia, Oxygen Desaturation, Respiratory Depression
Conditions
Keywords
Integrated Pulmonary Index, ERCP, SEDATİON, AİRWAY MANGEMENT, CAPNOGRAPHY, RESPİRATORY
Brief summary
This randomized controlled trial evaluates whether Integrated Pulmonary Index (IPI)-guided monitoring reduces oxygen desaturation and improves early detection of respiratory compromise during elective ERCP performed under standardized moderate sedation.
Detailed description
Adults undergoing elective ERCP are randomized 1:1 to standard monitoring alone or standard monitoring plus visible IPI (SpO₂, respiratory rate, pulse rate, and EtCO₂). Sedation is standardized (midazolam, fentanyl, ketamine) with a target RASS of -3 and routine supplemental oxygen. Oxygen desaturation (\>5% decrease in SpO₂ from baseline) during the procedure is the primary outcome. Secondary outcomes include hypoxemia (SpO₂ \<90%), apnea, bradypnea, and the frequency of airway interventions (verbal-tactile stimulation, jaw-thrust, head-tilt).
Interventions
DIAGNOSTIC_TESTIPI GROUP
Real-time monitoring of SpO₂, respiratory rate, pulse rate, and end-tidal CO₂ using capnography with visible IPI values to guide airway interventions during ERCP under moderate sedation.
DIAGNOSTIC_TESTCONTROL GROUP
Routine monitoring with ECG, non-invasive blood pressure, and pulse oximetry during ERCP under moderate sedation. IPI values are not displayed to the clinical team.
Sponsors
Merve Gökçe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
Parallel Assignment
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years, * Scheduled for elective ERCP, * ASA physical status I-IV * Ability to provide written informed consent
Exclusion criteria
* Age \<18 years * ASA physical status ≥V * Pregnancy or suspected pregnancy * Known allergy to study sedative agents * Obstructive or restrictive pulmonary disease * Pre-procedural supplemental oxygen therapy or non-invasive ventilation * Predicted difficult airway * Pre-procedural systolic blood pressure \<90 mmHg * Pre-procedural heart rate \<60 beats/min * Emergency ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Oxygen Desaturation | During the ERCP procedure | Occurrence of oxygen desaturation defined as a decrease in peripheral oxygen saturation (SpO₂) greater than 5% from baseline during the ERCP procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypoxemia | During the ERCP procedure | Occurrence of hypoxemia defined as SpO₂ \< 90% during the ERCP procedure. |
| Incidence of Apnea | During the ERCP procedure | Occurrence of apnea detected by capnography during the procedure |
Countries
Turkey (Türkiye)
Outcome results
None listed