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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03567928
Other study ID # 43/int/2018
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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 diseaseā€¦)

Study Design


Related Conditions & MeSH terms


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
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