Laryngeal Mask in Upper Gastrointestinal Procedures

Anesthesia Clinical Trial

— SeoMask  

Official title:

Anesthesiological Management of Ventilation With Laryngeal Mask in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound Procedures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03567928
• Other study ID #: 43/int/2018
• Status: Terminated
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in all patients. Some procedures are difficult to tolerate because of long duration, prone position or significant stimulation of the upper airways. An example are endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic pancreatic ultrasound.

The procedures are generally performed with deep sedation. Many pharmacologic regimens are available and described in literature. The investigator's institute adopts propofol target controlled infusion (TCI), which usually guarantees unconsciousness and unresponsiveness of patients. The main adverse event is dose-related respiratory depression. Pre-existing reasons for hypoventilation can exacerbate this event, especially in the elderly and the chronic obstructive pulmonary disease-patients. Laryngeal mask (LMA) is a useful tool to apply a pressure support ventilation. One specific type of LMA allows to separate the gastric and respiratory tract and, allows the anesthesiologist to support patient's ventilation as (and only if) necessary.

Description:

This is a monocentric randomized controlled trial of superiority of LMA use in GI endoscopic procedures. Randomization is centralized. The study is single blind (patient). The study is no-profit. Every patients undergoing scheduled ERCP and endoscopic ultrasound will be screened and consecutive eligible patients will be enrolled. Subjects will be allocated according to a simple randomization list. The study starts after randomization and ends after discharge from the recovery room. After peripheral venous catheter insertion and vital parameters monitoring, patients will receive propofol TCI with a tailored target between 4 and 6 mcg/ml. The treatment group will receive LMA insertion and End-Tidal Carbon Dioxide (ETCO2) monitoring throughout the procedure. In case of hypoventilation, with an ETCO2 above 50 mmHg, the patient will be supported as necessary with PSV. The control group will not receive any airway device, according to the standard treatment. At the end of the procedure, both group will receive a laboratory testing (peripheral arterial sample), when the patient is still sedated. Vital parameters monitoring will continue in recovery room. Patients will be discharge as usual with an Aldrete score > 9.

Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >18 years

• written informed consent

• elective ERCP and endoscopic ultrasound procedure

Exclusion Criteria:

• pregnancy

• contraindication to propofol administration

• contraindication to mask insertion (e.g. malformation)

• emergency operation (not scheduled)

• preexisting causes of hypoventilation (e.g. chronic obstructive pulmonary disease, neuromuscular disease…)

Related Conditions & MeSH terms

• Airway Device
• Anesthesia
• C.Surgical Procedure; Gastrointestinal

Intervention

Device:
• Sedation with Gastro Cuff Pilot Laryngeal Mask
This specific type of laryngeal mask allows to separate the gastric and respiratory tract and allows the anesthesiologist to support patient's ventilation as (and only if) necessary.

Drug:
• Propofol
Target controlled infusion (TCI) with propofol

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial Pressure of Carbon Dioxide (PaCO2)	PaCO2 level assessed by arterial sample	Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Secondary	Number of pressure support ventilation in treatment group	Number needing pressure support ventilation (PSV) in the treatment group. A PSV will be performed in case of End-Tidal carbon dioxide level raising above 50 mmHg.	During the procedure
Secondary	pH	pH assessed by arterial sample	Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Secondary	Partial Pressure of Oxygen (PaO2)	PaO2 level assessed by arterial sample	Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Secondary	Time to recover after the procedure	Time needed to recover: from arrival in recovery room to a Aldrete Score > 9	During recovery room stay (approximately 15-45 min after patient awakening)
Secondary	Satisfaction of the procedure operator	Satisfaction of the operator assessed by a Likert 5 points-scale: 1 "Strongly disagree"; 2 "Disagree"; 3 " Neutral/Neither agree nor disagree"; 4 "Agree"; 5 "Strongly agree"	1 minute after patient awakening
Secondary	Satisfaction of the patient	Satisfaction of the patient assessed by a Likert 5 points-scale: 1 "Strongly disagree"; 2 "Disagree"; 3 " Neutral/Neither agree nor disagree"; 4 "Agree"; 5 "Strongly agree"	20 minutes after patient awakening
Secondary	Number of completed endoscopic procedures	Number of completed endoscopic procedures without necessity to change anesthesiological treatment or postpone the procedure for any reason	During the procedure

External Links

•   LMA Gastro Cuff Pilot