Microaspiration in ERCP

• Conditions: Pulmonary Microaspiration
• Interventions: Radiation: Imaging

• Registration Number: NCT04831489
• Lead Sponsor: Theodor Bilharz Research Institute

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. apparent aspiration is noticeable however microaspiration is hard to detect clinically. our study aims at determining whether general anesthesia with endotracheal intubation or deep sedation is safer in ERCP patients.

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. In fact, with the wide use of ERCP, many critical patients in whom conventional surgery was a high-risk procedure could be managed by endoscopic treatment.

Compared to other endoscopic procedures, ERCP is considered a relatively longer and more complex one, with a substantially higher complication rate. Anesthetic techniques must facilitate the success of this procedure without adding to morbidity.

Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge.

Many anesthetic techniques are used, ranging from conscious sedation to general anesthesia. The worldwide accepted method is deep sedation in the presence of an anesthetist without endotracheal intubation. Intubation is recommended in very exceptional cases, for example is morbidly obese patients.

According to some authors, general anesthesia is less used as an anesthetic technique in ERCP; drawbacks of GA include: the lengthier time required for induction of and recovery from anesthesia which affects patients' turnover, the risk of residual neuromuscular blockade, the higher cost as well as ERCP is usually a day case procedure favoring the sedation technique. On the other hand, monitored anesthesia care or deep sedation in remote locations can avoid these drawbacks.

For ERCP cases, which can be very challenging, few studies have addressed what is the best anesthetic choice, i.e. deep sedation or general anesthesia with intubation. Significant complications such as aspiration, hypoxemia, and hypotension are potential risks in patients undergoing ERCP procedures, and important factors that can modify these events' severity include patients' ASA status, patients' hydration and oxygenation status, and monitoring techniques used during the procedure.

Perioperative pulmonary aspiration (POPA) may lead to clinically significant morbidities and/or mortality. The risk factors for pulmonary aspiration are usually overlooked unless the patient has a history of gastrointestinal diseases (for example gastroesophageal reflux disease, upper gastrointestinal bleeding, or intestinal obstruction). However, aspiration pneumonia is seldom observed in healthy patients undergoing regular endoscopy. On the other hand, prolonged or difficult procedures may be associated with increased risks of regurgitation and aspiration.

Apparent aspiration is a notable adverse event during gastrointestinal endoscopy, on the other hand, microaspiration is an underreported complication, and data about it is scarce. Since hypoxemia is a common manifestation of pulmonary aspiration and pulse oximetry monitoring is a routine practice, therefore, postoperative hypoxemia (POH) can be used as a potential signal for POPA.

There is no conclusive data to support or refuse the need for endotracheal intubation to avoid microaspiration during ERCP; therefore, the participants in the study decided to prospectively compare both techniques as regards the risk of microaspiration.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-03
• Study First Posted: 2021-04-05
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. ASA 1-3.
2. Age above 18 years old.
3. Preoperative pulmonary stability criteria (defined as a respiratory rate 12-24 breaths per minute, SpO2 ≥ 94% on room air) -

Exclusion Criteria

1. Age < 18 years.
2. Morbid obesity BMI ≥ 40 Kg/ m2.
3. Pregnancy.
4. Fasting ≤ 6 hours for solid food and ≤ 2 hours for clear liquids. 4
5. A pre-existing lung condition in patients requiring supplemental oxygen, inhalational bronchodilator, or systemic bronchodilator or steroid.
6. Patients in the intensive care unit and/or requiring mechanical ventilation prior to the procedure.
7. Previously intubated patients during the same hospitalization.
8. Tracheostomized patients.
9. Patients with swallowing disorders.
10. Bowel obstruction.
11. Anticipated difficult intubation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
deep sedation	Imaging	Anesthesia will be induced using titrated doses of propofol (0.5-1.5 mg/kg) and fentanyl (25-50 μg) initially to carefully maintain spontaneous breathing yet maintaining airway patency. Once adequate jaw relaxation is achieved, the endoscopy probe will be inserted. Maintenance of sedation will be carried out using propofol infusion between 80-120 mcg/kg/min. Additional dose 25-50 mg propofol will be given to the patient if spontaneous movement occurs
Genral anesthesia	Imaging	After mask pre-oxygenation, anesthesia will be induced with (2 mg/kg) propofol and (1 μg /kg) fentanyl. The neuromuscular blockade will be achieved with (0.5 mg/kg) atracurium followed by tracheal intubation. Anesthesia will be maintained to keep the end-tidal anesthetic concentrations within 1 MAC for sevoflurane. The neuromuscular blockade will be maintained with intermittent doses of atracurium (0.1mg/kg). Mechanical ventilation is adjusted with fresh gas flow oxygen in air 30-40% at a rate of 2 L/min to maintain end-tidal carbon dioxide of 35-40 mm Hg. Reversal of neuromuscular blockade will be achieved by intravenous administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg.

Primary Outcome Measures

Name	Time	Method
POPA	24 hours postoperatively	Perioperative Pulmonary Aspiration (POPA), which will be defined as the presence of an acute pulmonary infiltrate on chest CT within the 24 hours period following ERCP.

Secondary Outcome Measures

Name	Time	Method
Number of intraoperative hypoxic episodes.	24 hours postoperative.	Number of intraoperative hypoxic episodes in postoperative period

Trial Locations

Locations (1)

Theodor Bilharz research institute; 🇪🇬 Cairo, Egypt