Microaspiration in ERCP

Pulmonary Microaspiration Clinical Trial

Official title:

Risk of Pulmonary Micro-aspiration in Intubated vs Sedated Patients Undergoing ERCP

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04831489
• Other study ID #: Microaspiration in ERCP
• Status: Active, not recruiting
• Start date: April 1, 2021
• Est. completion date: February 2022

Study information

• Verified date: April 2021
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Microaspiration

Intervention

Radiation:
• Imaging
pre and postoperative CT scan of lung

Locations

Country	Name	City	State
Egypt	Theodor Bilharz research institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23. — View Citation

Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139. Review. — View Citation

Mazanikov M, Udd M, Kylänpää L, Lindström O, Aho P, Halttunen J, Färkkilä M, Pöyhiä R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005. — View Citation

Motiaa Y, Bensghir M, Jaafari A, Meziane M, Ahtil R, Kamili ND. Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled infusion versus standard volatile anesthesia. Ann Gastroenterol. 2016 Oct-Dec;29(4):530-535. Epub 2016 Jul 14. — View Citation

Shah SK, Mutignani M, Costamagna G. Therapeutic biliary endoscopy. Endoscopy. 2002 Jan;34(1):43-53. Review. — View Citation

Sorser SA, Fan DS, Tommolino EE, Gamara RM, Cox K, Chortkoff B, Adler DG. Complications of ERCP in patients undergoing general anesthesia versus MAC. Dig Dis Sci. 2014 Mar;59(3):696-7. doi: 10.1007/s10620-013-2932-2. Epub 2013 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POPA	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.	24 hours postoperatively
Secondary	Number of intraoperative hypoxic episodes.	Number of intraoperative hypoxic episodes in postoperative period	24 hours postoperative.