Laryngeal Mask in Upper Gastrointestinal Procedures

NCT03567928 | Terminated DMC

• 1 other identifier: 43/int/2018
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Airway Device; C.Surgical Procedure; Gastrointestinal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of pressure support ventilation in treatment group

  During the procedure

• pH

  Just before patient awakening (approximately 90-120 min after induction of anesthesia)

• Partial Pressure of Oxygen (PaO2)

  Just before patient awakening (approximately 90-120 min after induction of anesthesia)

• Time to recover after the procedure

  During recovery room stay (approximately 15-45 min after patient awakening)

• Satisfaction of the procedure operator

  1 minute after patient awakening

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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

Drug: Propofol

Interventional Treatment

EXPERIMENTAL

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

Device: Sedation with Gastro Cuff Pilot Laryngeal Mask; Drug: Propofol

Interventions

Sedation with Gastro Cuff Pilot Laryngeal Mask 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.

Interventional Treatment

Propofol DRUG

Target controlled infusion (TCI) with propofol

Interventional Treatment; Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years
• written informed consent
• elective ERCP and endoscopic ultrasound procedure

You may not qualify if:

• 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…)

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Milano, 20131, Italy

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Massimo Agostoni, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Induction of anesthesia and subsequent use (or not) of the device (laryngeal mask)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups: one receive sedation in spontaneous breathe, the other receive sedation with laryngeal mask

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 26, 2018
• Study Start: September 26, 2018
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)