A Comparison of a Polyvinyl Chloride Tubes With the Wire-Reinforced Tube for Tracheal Intubation Through a SaCO LMA

A Comparison of a Polyvinyl Chloride Tubes With the Wire-Reinforced Tube for Tracheal Intubation Through a SaCO Laryngeal Mask Airway in Patients With Normal Airways Undergoing General Anesthesia : a Randomized Controlled Study

To compare the Polyvinyl Chloride Tube With the Wire-Reinforced Tube for Tracheal Intubation through the SaCo visual laryngeal mask, to observe the success rate of intubation and the incidence of postoperative adverse reactions, and to explore the best type of endotracheal tube through the SaCo visual laryngeal mask, so as to provide reference for its clinical application.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Procedure: Polyvinyl Chloride Tube group; Procedure: Wire-Reinforced Tube group

Detailed Description

1. At present, there are few studies on intubation through SaCo visual laryngeal mask. It is proposed that endotracheal intubation through SaCo visual laryngeal mask is to verify its feasibility.
2. The purpose is to explore the best type of endotracheal tube by observing the success rate of intubation through SaCo visual laryngeal mask and the incidence of postoperative adverse reactions.
3. By observing the hemodynamic changes of the Polyvinyl Chloride Tubes and the Wire-Reinforced Tube during intubation through SaCo visual laryngeal mask, the effects of the two tracheal tubes on the hemodynamics of patients were compared.
4. By observing the optimized operation which can improve the success rate of tracheal intubation in the experiment, it can be better applied in clinical practice.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Yongtao Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients scheduled to accept elective laparoscopic surgery under general anesthesia;
2. Patients older than 18 years and younger than 70 years;
3. Patients of Body Mass Index (BMI) greater than 18.5 kg/m2 and less than27.9 kg/m2;
4. Patients of The American Society of Anesthesiologists ( ASA ) Ⅰ- Ⅲ level grade;

Exclusion Criteria:

1. Patients who have neurological or psychiatric diseases (such as schizophrenia, depression, etc.) or unconscious;
2. Patients with severe cardiopulmonary dysfunction;
3. Patients with vocal cord injury, pharynx disease or history of neck surgery;
4. Patients with risk of reflux aspiration and indwelling nasogastric tube before and after surgery;
5. Patients with degree of mouth opening less than 2cm, Modified Mallampati Score IV;
6. Patients with EVGS (laryngoscope endoscope grading system) grade 3 or 4;
7. Patients who have participated in other clinical studies during the last 3 months;
8. Patients rufused to sign the informed consent form for the clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyvinyl Chloride Tube group; Polyvinyl Chloride tube is made of hard material and has a certain radian.After anesthesia induction,the SaCo laryngeal mask is successfully inserted then through the laryngeal mask visual screen for EVGS grade. If the grade is 1 or 2, the tracheal tube with the curvature of the tube facing upwards would be inserted through the SaCo laryngeal mask under the guidance of the visual screen. Intubation is considered successful if the endotracheal tube slid through the LMA without any resistance and tracheal intubation would be confirmed by the laryngeal mask visual screen and the detection of end-tidal CO2. If tracheal intubation is unsuccessful after the first attempt, the tube would be pulled 2 cm, rotated tube, and then advanced. If this attempt is unsuccessful, the tube would be pulled again 2 cm, adjust the laryngeal mask by up-down maneuver and assist in rotating tube, and then advanced.	Procedure: Polyvinyl Chloride Tube group; After anesthesia induction,the SaCo laryngeal mask is successfully inserted then through the laryngeal mask visual screen for EVGS grade. If the grade is 1 or 2, the tracheal tube with the curvature of the tube facing upwards would be inserted through the SaCo laryngeal mask under the guidance of the visual screen. Intubation is considered successful if the endotracheal tube slid through the LMA without any resistance and tracheal intubation would be confirmed by the laryngeal mask visual screen and the detection of end-tidal CO2. If tracheal intubation is unsuccessful after the first attempt, the tube would be pulled 2 cm, rotated tube, and then advanced. If this attempt is unsuccessful, the tube would be pulled again 2 cm, adjust the laryngeal mask by up-down maneuver and assist in rotating tube, and then advanced.
Experimental: Wire-Reinforced Tube group; Wire-Reinforced tube is made of softer material and has no certain radian.After anesthesia induction,the SaCo laryngeal mask is successfully inserted then through the laryngeal mask visual screen for EVGS grade. If the grade is 1 or 2, the tracheal tube with the curvature of the tube facing upwards would be inserted through the SaCo laryngeal mask under the guidance of the visual screen. Intubation is considered successful if the endotracheal tube slid through the LMA without any resistance and tracheal intubation would be confirmed by the laryngeal mask visual screen and the detection of end-tidal CO2. If tracheal intubation is unsuccessful after the first attempt, the tube would be pulled 2 cm, rotated tube, and then advanced. If this attempt is unsuccessful, the tube would be pulled again 2 cm, adjust the laryngeal mask by up-down maneuver and assist in rotating tube, and then advanced.	Procedure: Wire-Reinforced Tube group; After anesthesia induction,the SaCo laryngeal mask is successfully inserted then through the laryngeal mask visual screen for EVGS grade. If the grade is 1 or 2, the tracheal tube with the curvature of the tube facing upwards would be inserted through the SaCo laryngeal mask under the guidance of the visual screen. Intubation is considered successful if the endotracheal tube slid through the LMA without any resistance and tracheal intubation would be confirmed by the laryngeal mask visual screen and the detection of end-tidal CO2. If tracheal intubation is unsuccessful after the first attempt, the tube would be pulled 2 cm, rotated tube, and then advanced. If this attempt is unsuccessful, the tube would be pulled again 2 cm, adjust the laryngeal mask by up-down maneuver and assist in rotating tube, and then advanced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total success rate of intubation	the tracheal tube with the curvature of the tube facing upwards would be inserted through the SaCo laryngeal mask under the guidance of the visual screen. Intubation is considered successful if the endotracheal tube slid through the LMA without any resistance and tracheal intubation would be confirmed by the laryngeal mask visual screen and the detection of end-tidal CO2. If tracheal intubation is unsuccessful after the first attempt, the tube would be pulled 2 cm, rotated tube, and then advanced. If this attempt is unsuccessful, the tube would be pulled again 2 cm, adjust the laryngeal mask by up-down maneuver and assist in rotating tube, and then advanced. If tracheal intubation is accomplished after either maneuver, this is considered a success.	From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to half hour or 1 hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The first success rate of intubation	After anesthesia induction.the tracheal tube with the curvature of the tube facing upwards would be inserted through the SaCo laryngeal mask under the guidance of the visual screen. Intubation is considered successful if the endotracheal tube slid through the LMA without any resistance and tracheal intubation would be confirmed by the laryngeal mask visual screen and the detection of end-tidal CO2.	From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Time of endotracheal intubation	The time of intubation was classified to seeing three complete end-tidal CO2 cycles on the monitor, tidal volume 6-8ml/kg, respiratory rate 12 beats / min.	From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
The sites of obstruction for the first time.	The sites of obstruction are identified with the laryngeal mask visual screen. Four areas were defined based on the glottic opening: the interarytenoid fold, the left and right aryepiglottic, the vestibularand vocal folds, and the tubercule of the epiglottis.	From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
The adjustment action for tracheal intubation	If tracheal intubation is unsuccessful after the first attempt, the tube would be pulled 2 cm, rotated tube, and then advanced. If this attempt is unsuccessful, the tube would be pulled again 2 cm, adjust the laryngeal mask by up-down maneuver and assist in rotating tube, and then advanced. If tracheal intubation is accomplished after either maneuver, this is considered a success and the maneuver used would be documented.	From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Hemodynamic fluctuation	hemodynamic fluctuation during intubation and extubation.The levels of SBP,DBP,MAP and HR basic(T0) , after induction(T1), Immediately(T2) and 3 minutes(T3) after insertion of laryngeal mask, Immediately(T4) and 3 minutes(T5) after endotracheal intubation ,Before(T6) and after(T7) extubation were recorded.	It will take up to half hour or 1 hour.
The number of patients with postoperative sore throat	Sore throats can be evaluated using the Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain).	one day after the surgery.
The number of patients with postoperative hoarseness	Hoarseness was classified as mild, moderate and severe according to the severity.	one day after the surgery.
The number of patients with postoperative dysphagia	Postoperative dysphagia was classified as mild, moderate and severe according to the severity.	one day after the surgery.

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Yongtao Sun, doctor, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 25, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: endotracheal intubation; supraglottic airway devices; laryngeal mask airway; SaCO visual laryngeal mask airway; intubating laryngeal mask airway
• Other Study ID Numbers: SACOVLM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No