Laryngeal Mask in Upper Gastrointestinal Procedures (SeoMask)

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

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia; C.Surgical Procedure; Gastrointestinal; Airway Device
• Intervention / Treatment: Drug: Propofol; Device: Sedation with Gastro Cuff Pilot Laryngeal Mask

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Milan, Milano, Italy, 20131
      • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Treatment; Standard Treatment Sedation with propofol target controlled infusion (TCI) and no airway devices (mandatory spontaneous breathe)	Drug: Propofol; Target controlled infusion (TCI) with propofol
EXPERIMENTAL: Interventional Treatment; Interventional Treatment Sedation with propofol target controlled infusion (TCI) and Gastro Cuff Pilot Laryngeal Mask (possibility to use a pressure-support ventilation)	Drug: Propofol; Target controlled infusion (TCI) with propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
pH	pH assessed by arterial sample	Just before patient awakening (approximately 90-120 min after induction of anesthesia)
Partial Pressure of Oxygen (PaO2)	PaO2 level assessed by arterial sample	Just before patient awakening (approximately 90-120 min after induction of anesthesia)
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)
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
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
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

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele
• Investigators: Principal Investigator: Massimo Agostoni, MD, Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 26, 2018
• Primary Completion (ACTUAL): April 10, 2019
• Study Completion (ACTUAL): April 10, 2019

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 43/int/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No