Laryngeal Mask in Upper Gastrointestinal Procedures

NCT ID: NCT03567928

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2019-04-10

Brief 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.

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.

Conditions

Anesthesia; Airway Device; C.Surgical Procedure; Gastrointestinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Treatment

Standard Treatment Sedation with propofol target controlled infusion (TCI) and no airway devices (mandatory spontaneous breathe)

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Target controlled infusion (TCI) with propofol

Interventional Treatment

Interventional Treatment Sedation with propofol target controlled infusion (TCI) and Gastro Cuff Pilot Laryngeal Mask (possibility to use a pressure-support ventilation)

Group Type: EXPERIMENTAL

Sedation with Gastro Cuff Pilot Laryngeal Mask

Intervention Type: DEVICE

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.

Propofol

Intervention Type: DRUG

Target controlled infusion (TCI) with propofol

Interventions

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.

Intervention Type: DEVICE

Propofol

Target controlled infusion (TCI) with propofol

Intervention Type: DRUG

Eligibility Criteria

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…)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Agostoni Massimo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Agostoni, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele

Locations

San Raffaele Hospital

Milan, Milano, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

43/int/2018

Identifier Type: -

Identifier Source: org_study_id