Airway Aspiration, Airway Complication of Anesthesia, Bleeding Nose, Bronchospasm, Complication of Anesthesia, Endoscopic Ergonomics, ERCP Airway Management, Esophagus Injury, Supraglottic Airway Efficiency
Conditions
Keywords
Wei Nasal Jet Tube, Gastro-laryngeal tube, ERCP, Airway Complication, Hipoxia
Brief summary
The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures.
Detailed description
ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and deep levels of anesthesia. The procedure can be performed under general anesthesia or with deep sedation. It becomes more difficult to maintain airway patency in the prone position under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be tolerated with less depth levels of anesthesia. It has been reported in the literature that GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP procedures. However, both airway devices have not been compared for airway efficiency and ERCP procedure condition. In this study, the investigators aimed to compare airway efficiency and procedure condition using GLT and WNJ.
Interventions
DEVICEWei Nasal Jet Tube
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures airway devices which can use for gastrointestinal procedures
DEVICEGastro Laryngeal Tube
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Single (Participant) closed envelope technique
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA Physical Status 1-2 * Elective Procedures * Body mass index 18.5 - 35 kg/m2
Exclusion criteria
* High risk of pulmonary aspiration * Pregnancy * Anesthesic drug allergies * Difficult airway or facial deformities * Height \<155 cm * Alcohol or narcotic drug usage * Restrictive or obstructive pulmonary diseases * Hepatic cardiac or renal failure * Neurologic or cognitive deficiencies. * Previous cervical surgery or cervical radiotherapy * Previous esophagus surgery * Psychotic problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia İncidence | Intra-operative; after device insertion | Hypoxia is defined as SpO2 \<92% at any time. |
| Endoscopist Satisfaction Analysis: Score | Intra-operative, during the procedure | It is determined by the endoscopist according to the endoscopy satisfaction scale according to the maneuverability of the duodenoscope and the number of insertion attempts. (0-10 Points) The endocopist satisfaction score is scored on a minimum score of 0 and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood staining on the device | Immediately after removing the supraglottic airway device | Whether there is blood on the supraglottic airway device or not |
| Presence of sore throat | One hour after extubation | Sore throat if present, was classified as mild, moderate or severe. |
| Incidence of hypercapnia | Intra-operative; after device insertion | Hypercapnia is EtCO2 \>45 mmHg at any time during the procedure |
Countries
Turkey (Türkiye)
Outcome results
None listed