Airway Device, Anesthesia, C.Surgical Procedure; Gastrointestinal
Conditions
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.
Interventions
DEVICESedation 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.
DRUGPropofol
Target controlled infusion (TCI) with propofol
Sponsors
Ospedale San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Induction of anesthesia and subsequent use (or not) of the device (laryngeal mask)
Intervention model description
Two groups: one receive sedation in spontaneous breathe, the other receive sedation with laryngeal mask
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Pressure of Carbon Dioxide (PaCO2) | Just before patient awakening (approximately 90-120 min after induction of anesthesia) | PaCO2 level assessed by arterial sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of the patient | 20 minutes after patient awakening | 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 |
| Number of pressure support ventilation in treatment group | During the procedure | 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. |
| pH | Just before patient awakening (approximately 90-120 min after induction of anesthesia) | pH assessed by arterial sample |
| Satisfaction of the procedure operator | 1 minute after patient awakening | 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 |
| Time to recover after the procedure | During recovery room stay (approximately 15-45 min after patient awakening) | Time needed to recover: from arrival in recovery room to a Aldrete Score \> 9 |
| Number of completed endoscopic procedures | During the procedure | Number of completed endoscopic procedures without necessity to change anesthesiological treatment or postpone the procedure for any reason |
| Partial Pressure of Oxygen (PaO2) | Just before patient awakening (approximately 90-120 min after induction of anesthesia) | PaO2 level assessed by arterial sample |
Countries
Italy
Outcome results
None listed