Hypoxemia, Hemodynamic Instability
Conditions
Keywords
ERCP, high-flow nasal oxygen, procedural sedation, geriatric, hypoxaemia, Hemodynamic Instability
Brief summary
This prospective, single-centre, randomized controlled trial evaluates whether high-flow nasal oxygen (HFNO) reduces hypoxaemia compared with conventional low-flow oxygen therapy (COT) during endoscopic retrograde cholangiopancreatography (ERCP) performed under sedation in geriatric and adult patients. One hundred ASA I-III patients undergoing ERCP were stratified by age (\<65 and ≥65 years) and randomized to receive HFNO or COT. The primary outcome is the incidence of hypoxaemia (SpO₂ ≤90%). Secondary outcomes include hypotension, haemodynamic changes, sedative consumption, and recovery time.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is a complex gastrointestinal endoscopic procedure frequently performed under deep sedation. Due to the prone position, prolonged procedural duration, and sedative-induced respiratory depression, ERCP is associated with an increased risk of cardiopulmonary complications, particularly hypoxaemia and haemodynamic instability. These risks are more pronounced in geriatric patients because of age-related reductions in respiratory reserve, impaired ventilatory response to hypercapnia, and diminished cardiovascular compensatory mechanisms. Conventional oxygen therapy (COT) delivered via low-flow nasal cannula is routinely used during sedated ERCP. However, low-flow systems may provide inconsistent inspired oxygen concentrations and do not generate positive airway pressure. High-flow nasal oxygen (HFNO) delivers heated and humidified oxygen at high flow rates, allowing for stable fractional inspired oxygen (FiO₂) delivery, nasopharyngeal dead space washout, and generation of a low level of positive end-expiratory pressure (PEEP). These physiological effects may improve oxygenation and reduce hypoxaemic events during procedural sedation. The present study was designed as a prospective, single-centre, age-stratified, parallel-group randomized controlled trial to compare HFNO and COT in adult (\<65 years) and geriatric (≥65 years) patients undergoing ERCP under sedation. A total of 100 ASA physical status I-III patients scheduled for ERCP were enrolled. Patients were stratified by age and randomized in a 1:1 ratio within each stratum to receive either HFNO or COT, resulting in four groups: Adult + HFNO Geriatric + HFNO Adult + COT Geriatric + COT Sedation was standardized across groups. All patients received pre-procedural midazolam and topical lidocaine anesthesia. Sedoanalgesia was achieved using fentanyl and propofol, followed by maintenance with a ketofol infusion (ketamine-propofol mixture). Drug dosages were adjusted according to age and clinical response. Standard intra-procedural monitoring included heart rate, non-invasive blood pressure, peripheral oxygen saturation (SpO₂), and end-tidal carbon dioxide (EtCO₂). HFNO was delivered at a flow rate of 50 L/min with FiO₂ of 0.50 and temperature of 37°C. In cases of desaturation, flow was increased up to 60 L/min and FiO₂ up to 100% if required. Conventional oxygen therapy consisted of 4 L/min oxygen via nasal cannula.
Interventions
DEVICEHFNO
Heated and humidified high-flow nasal oxygen delivered during ERCP under sedation using a high-flow nasal cannula system. Oxygen was administered at a flow rate of 50 L/min with an initial FiO₂ of 0.50 and temperature set at 37°C. In cases of oxygen desaturation (SpO₂ ≤90%), flow was increased up to 60 L/min and FiO₂ up to 1.0 if required. Continuous monitoring of SpO₂, heart rate, blood pressure, and end-tidal CO₂ was performed throughout the procedure.
Conventional low-flow oxygen therapy delivered via standard nasal cannula during ERCP under sedation. Oxygen was administered at a fixed flow rate of 4 L/min. Patients were continuously monitored for oxygen saturation, heart rate, blood pressure, and end-tidal CO₂ throughout the procedure.
Sponsors
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Patients scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP) * Planned sedation with monitored anesthesia care * ASA physical status I-III * Ability to provide written informed consent * Adult group: 18-64 years * Geriatric group: ≥65 years
Exclusion criteria
* Severe cardiac, pulmonary, renal, neurological, or hepatic disease * Baseline hypotension (systolic arterial pressure \<90 mmHg) or uncontrolled hypertension (systolic arterial pressure \>170 mmHg, diastolic pressure \>100 mmHg) * Pre-existing hypoxaemia (SpO₂ \<90%) * Known hypersensitivity to study medications or a history of sedation-related adverse events * Use of sedative medication within 24 hours prior to the procedure * Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypoxemia during ERCP | During the ERCP procedure |
Countries
Turkey (Türkiye)
Outcome results
None listed