Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM

• ClinicalTrials.gov Identifier: NCT05338827
• Recruitment Status: Recruiting
• First Posted: April 21, 2022
• Last Update Posted: February 2, 2023
• Sponsor: Qianfoshan Hospital
• Information provided by (Responsible Party): Yongtao Sun, Qianfoshan Hospital

Study Description

Brief Summary:

To compare a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway, 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 SaCoVLM video laryngeal mask airway, so as to provide reference for its clinical application.

Condition or disease	Intervention/treatment	Phase
Laparoscopic Surgery	Procedure: Polyvinyl Chloride Tube group; Procedure: Wire-Reinforced Tube group	Not Applicable

Detailed Description:

1. At present, there are few studies on intubation through SaCoVLM video laryngeal mask airway. It is proposed that endotracheal intubation through SaCoVLM video laryngeal mask airway 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 SaCoVLM video laryngeal mask airway 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 SaCoVLM video laryngeal mask airway , 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM Video Laryngeal Mask Airway: a Randomized Controlled Study
• Actual Study Start Date: May 1, 2022
• Estimated Primary Completion Date: May 1, 2023
• Estimated Study Completion Date: August 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Polyvinyl Chloride Tube group; The PVC tube used is a stiff tube with an anterior curvature of approximately 130°, which retains the additional curvature imposed by its passage through the ventilation conduit of the ILMA. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.	Procedure: Polyvinyl Chloride Tube group; The anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.
Experimental: Wire-Reinforced Tube group; In contrast to the PVC tube, the WR tube is flexible with a slightly anterior curvature. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.	Procedure: Wire-Reinforced Tube group; The anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.

Outcome Measures

Primary Outcome Measures :

1. The total success rate of tracheal intubation [ Time Frame: 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. ]
   defined as the cumulative third-attempt intubation success rate

Secondary Outcome Measures :

1. Successful insertion rate on the first attempt [ Time Frame: 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. ]
   tracheal intubation is considered successful if the endotracheal tube slides through the LMA without any resistance, and tracheal intubation was confirmed by the laryngeal mask visual screen and detection of end-tidal carbon dioxide (CO2).
2. Time of tracheal intubation [ Time Frame: 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. ]
   defined as the time from picking up the tracheal tube to the appearance of three standard end-tidal CO2 waveforms on the monitor.
3. Site of first contact of tracheal intubation [ Time Frame: 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. ]
   which will be identified with the SaCoVLM visual screen (four areas are defined based on the glottic opening: the interarytenoid fold, the left and right aryepiglottic, the vestibular and vocal folds, and the tubercle of the epiglottis).8
4. Adjustment action for tracheal intubation [ Time Frame: 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. ]
   if tracheal intubation is unsuccessful after the first attempt, the tube will be pulled 2 cm, rotated and then advanced. If this attempt is unsuccessful, the tube will again be pulled 2 cm, adjusted to the SaCoVLM by the up-down manoeuvre, rotated and then advanced. If tracheal intubation is accomplished after either manoeuvre, this is considered a success and the manoeuvre used would be documented.
5. Haemodynamic fluctuation [ Time Frame: It will take up to half hour or 1 hour. ]
   the systolic and diastolic blood pressure, mean arterial pressure and HR after induction, immediately, and 3 min after insertion of the laryngeal mask; immediately and 3 min after tracheal intubation; 3 min before extubation; and immediately and 3 min after extubation are recorded.
6. Incidence of trauma as evidenced by blood [ Time Frame: It will take up to half hour or 1 hour. ]
   incidence of trauma as evidenced by blood on ILMA or endotracheal tube after removal
7. Incidence rate of postoperative sore throat, hoarseness and dysphagia at 24 hours after the surgery [ Time Frame: one day after the surgery. ]
   the severity of sore throat will be evaluated using a numerical rating scale (0=no sore throat, 10=worst sore throat imaginable). Hoarseness will be classified as mild, moderate or severe (overall dysphonia grade, roughness, breathiness, asthenia and strain score). Dysphagia will be classified as normal, mild, moderate or severe according to the severity.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Scheduled to accept elective laparoscopic surgery under general anaesthesia.
2. Aged 18-70 years.
3. Body mass index (BMI) 18.5-27.9 kg/m2.
4. ASA class I-III.

Exclusion Criteria:

1. Neurological or psychiatric diseases (such as schizophrenia and depression), or unconscious.
2. Severe cardiopulmonary dysfunction.
3. Vocal cord injury, pharyngeal disease or history of neck surgery.
4. Risk of reflux aspiration and indwelling nasogastric tube before and after surgery.
5. Mouth opening less than 2 cm, limitation of cervical extension, modified Mallampati score IV.
6. SaCoVLM glottic exposure grade 3 or 4.
7. Participated in other clinical studies during the last 3 months.
8. Refused to give informed consent for the clinical study.

Contacts and Locations

Contacts

Contact: Yongtao Sun, doctor; 18660795201; sunyongtao1979@163.com

Locations

China, Shandong

Yongtao Sun; Recruiting

Jinan, Shandong, China, 250000

Contact: Yongtao Sun, doctor 18660795201 sunyongtao1979@163.com

Sponsors and Collaborators

Qianfoshan Hospital

Investigators

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

More Information

• Responsible Party: Yongtao Sun, Professor, Qianfoshan Hospital
• ClinicalTrials.gov Identifier: NCT05338827
• Other Study ID Numbers: SaCoVLM
• First Posted: April 21, 2022
• Last Update Posted: February 2, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Yongtao Sun, Qianfoshan Hospital:

SaCO Video Laryngeal Mask Airway; intubating laryngeal mask airway; laryngeal mask airway; supraglottic airway devices; endotracheal intubation