Laryngeal Mask in Upper Gastrointestinal Procedures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Airway Device, C.Surgical Procedure; Gastrointestinal

Intervention / Treatment
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* Device: Sedation with Gastro Cuff Pilot Laryngeal Mask
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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…)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups: one receive sedation in spontaneous breathe, the other receive sedation with laryngeal mask
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment<br>Standard Treatment Sedation with propofol target controlled infusion (TCI) and no airway devices (mandatory spontaneous breathe) | Drug: Propofol<br>* Target controlled infusion (TCI) with propofol<br>|
| Experimental: Interventional Treatment<br>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<br>* 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.<br>Drug: Propofol<br>* Target controlled infusion (TCI) with propofol<br>|

What is the study measuring?
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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 |