A Randomized, Controlled, Unblinded Trial Evaluating Positive Airway Pressure and Capnometry Compared to Standard Care to Reduce Desaturation During Nurse-Administered Sedation ERCP

What this Trial Is About

Desaturation, a drop in blood oxygen levels, is a common complication during sedation for endoscopic retrograde cholangiopancreatography (ERCP), occurring in up to 30% of cases. This trial aims to study whether using devices for airway management or enhanced respiratory monitoring can reduce desaturation incidents during ERCP procedures. The study is a prospective, randomized, open-label trial comparing different respiratory approaches in adult patients undergoing ERCP. Participants will be randomly assigned to one of three groups: one group will receive airway management using a nasal positive airway pressure (PAP) ventilation system, another will have additional monitoring with capnometry alongside low-flow oxygen via nasal cannula, and the control group will receive standard care with low-flow oxygen via nasal cannula. Each patient is monitored during the ERCP procedure for oxygen saturation and other vital signs, and all desaturation events below 85% oxygen saturation are recorded and managed according to guidelines. After the procedure, participants will be followed passively for 30 days through medical record review to identify any late complications. The main measurement is the difference in the rate of desaturation events between the PAP and control groups. Other measures include interventions for low oxygen events, lowest oxygen levels during the procedure, procedure length, sedation satisfaction, and sedation-related adverse events. The total involvement includes the ERCP procedure and a 30-day follow-up period.

Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP