Comparison of Procedural Oxygen Mask vs. Conventional Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxemia
- Sponsor
- Kocaeli City Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- incidence of hypoxemia
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an imaging procedure that visualizes the drainage ducts of the pancreas, gallbladder, and liver through the use of a duodenoscope and contrast media. By endoscopically identifying the ampulla of Vater, the common bile duct is cannulated. ERCP is also frequently utilized for therapeutic interventions, such as endoscopic sphincterotomy, bile duct stone extraction, stent placement in malignant and benign biliary strictures, and biopsy collection, thus playing a critical role in both the diagnosis and treatment of pancreatobiliary disorders.
ERCP, being more invasive than routine upper endoscopies or colonoscopies, typically necessitates deeper levels of sedation. The procedure is performed in the prone, modified prone, or lateral decubitus position, which increases the risk of hypoxemia and hypoventilation due to upper airway obstruction. Furthermore, endoscopic instruments inserted through the oral cavity limit anesthesiologists' access to the patient's airway, thereby restricting ventilation support during gastrointestinal endoscopy. Ensuring airway stability during sedation is paramount for patient safety and procedural efficacy. Currently, a range of devices, including traditional nasal cannulas, high-flow oxygen masks, and procedural oxygen masks, are routinely employed to provide oxygen support throughout the procedure.
The existing literature includes randomized controlled trials and systematic reviews aimed at preventing hypoxemia during ERCP. Through this study, investigators aim to make a novel contribution to the literature by assessing the effectiveness of a recently introduced procedural oxygen mask.
Detailed Description
This study aims to compare the efficacy of different oxygen delivery methods (Nasal Cannula \[NC\] and Procedural Oxygen Mask \[POM\]) in preventing the incidence of hypoxemia during Endoscopic Retrograde Cholangiopancreatography (ERCP). Designed as a randomized controlled prospective study, participants were assigned into two groups, Group N (NC) and Group P (POM), at a 1:1 ratio through randomization. The randomization was performed using computer-assisted random allocation; however, due to the visual differences in the oxygen delivery devices, neither healthcare providers nor patients could be blinded to the randomization results. A power analysis conducted to establish a statistical power of 80% and an alpha level of 0.05 indicated that a total of 140 patients, with 70 patients in each group, should be included in the study. Considering potential dropouts, 150 patients will be included in the study This evaluation ensures that an adequate sample size is obtained to detect a significant difference in the incidence of hypoxemia. Throughout the ERCP procedure, all patients will be monitored using pulse oximetry, electrocardiography (ECG), and non-invasive blood pressure monitoring. Capnography will be applied in both groups, and necessary interventions will be carried out by anesthesia specialists if a patient's oxygen saturation falls below 90%. All interventions and events will be meticulously documented. Following the procedure, patients will be monitored in the post-anesthesia care unit (PACU), and those with a Post-Anesthesia Discharge Scoring System (PADSS) score of 9 or higher will be discharged. Anesthesia Management The oxygen flow rate will be maintained constant throughout the procedure. Initially, patients will receive midazolam at a dose of 0.02 mg/kg, followed by 0.3 mg/kg of ketamine. To ensure sedation, propofol will be administered as an initial bolus dose of 0.5-1.0 mg/kg; further bolus doses of 0.25-0.5 mg/kg will be given every 1-3 minutes to maintain the desired sedation level. The target sedation level will be aimed at 3-4 on the Ramsay Sedation Scale (RSS), and these target values will be preserved during the procedure. Upon completion of the procedure, patients will be awakened using verbal and tactile stimuli; once the RSS reaches 2, they will be transferred to the PACU. In the PACU, patients will be discharged if they achieve a PADSS score of 9 or above. Oxygen Reserve Index (ORi) measurement will performed on all patients. The ORi value will measured and recorded at the plateau level during the preoxygenation stage (as the baseline), immediately after the start of the procedure, at the end of the procedure, and the highest ORi value measured throughout the procedure Vital signs, procedure durations, and dosages of medications used for each patient will be meticulously recorded. All anesthesia-related decisions during the procedure will be made by the supervising anesthesia specialist.
Investigators
Bedirhan Günel
Principal Investigator
Kocaeli City Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 18-75 years
- •American Society of Anesthesiologists (ASA) classification of 1-2-3
- •Patients scheduled for ERCP at Kocaeli City Hospital Endoscopy Unit
Exclusion Criteria
- •Patients who refuse to participate in the study
- •Patients with allergies to ketamine, propofol, or midazolam
- •Patients diagnosed with psychiatric disorders
- •Patients with a body mass index (BMI) \>30 kg/m²
- •Patients with cognitive impairment, dementia, or communication issues
- •Pregnant patients or those in the postpartum period
- •Patients diagnosed with sleep apnea syndrome
- •History of intubation within the last 3 months
- •History of lower respiratory tract infection within the last 3 months
- •History of intensive care unit admission within the last 3 months
Outcomes
Primary Outcomes
incidence of hypoxemia
Time Frame: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
The incidence of hypoxemia during sedation (defined as SpO2 \< 90%). SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.
Secondary Outcomes
- Number of hypoxemia episodes(Continuous SpO2 monitoring will be performed throughout the ERCP procedure)
- Duration of hypoxemia(Continuous SpO2 monitoring will be performed throughout the ERCP procedure)
- Minimum SpO2 value observed during the procedure(Continuous SpO2 monitoring will be performed throughout the ERCP procedure)
- Oxygen Reserve Index (as the baseline)(Continuous Oxygen Reserve Index monitoring will be performed after prepreoxygenation)
- Oxygen Reserve Index (immediately after the start of the procedure)(Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure)
- Oxygen Reserve Index (at the end of the procedure)(Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure)
- Oxygen Reserve Index (highest ORi value will be measured)(Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure)
- airway management(Interventions related to airway management causing interruptions during the procedure)
- Other potential complications(during the procedure)
- Number of Participants with Early Termination of Procedure Due to Sedation(during the procedure)
- ERCP duration(up to 60 minutes (or the estimated average duration of the procedure))
- Recovery time(up to a maximum of 90 minutes (or the estimated average recovery time for the procedure))
- Discharge time(assessed during the recovery period, up to a maximum of 120 minutes (or the estimated average time for the procedure recovery))
- Gastroenterologist satisfaction(with data reported immediately following the completion of the procedure.)
- Postoperative nausea, vomiting, pain, aspiration, and other potential complications(Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after the procedure.")
- Patient satisfaction related to anesthesia(Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after the procedure.")