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

Tracking Information

• First Submitted Date: April 14, 2022
• First Posted Date: April 21, 2022
• Last Update Posted Date: February 2, 2023
• Actual Study Start Date: May 1, 2022
• Estimated Primary Completion Date: May 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2023)

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

Original Primary Outcome Measures (submitted: April 14, 2022)

Total success rate of 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. ]

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.

Current Secondary Outcome Measures (submitted: January 31, 2023)

• 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).
• 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.
• 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
• 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.
• 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.
• 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
• 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.

Original Secondary Outcome Measures (submitted: April 14, 2022)

• The first success rate of 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. ]
  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.
• Time of endotracheal 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. ]
  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.
• The sites of obstruction for the first time. [ 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. ]
  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.
• The 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 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.
• Hemodynamic fluctuation [ Time Frame: It will take up to half hour or 1 hour. ]
  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.
• The number of patients with postoperative sore throat [ Time Frame: one day after the surgery. ]
  Sore throats can be evaluated using the Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain).
• The number of patients with postoperative hoarseness [ Time Frame: one day after the surgery. ]
  Hoarseness was classified as mild, moderate and severe according to the severity.
• The number of patients with postoperative dysphagia [ Time Frame: one day after the surgery. ]
  Postoperative dysphagia was classified as mild, moderate and severe according to the severity.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM
• 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
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Screening
• Condition: Laparoscopic Surgery

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Procedure: Polyvinyl Chloride Tube group
• 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.
  Intervention: Procedure: Wire-Reinforced Tube group

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 14, 2022): 104
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2023
• Estimated Primary Completion Date: May 1, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05338827
• Other Study ID Numbers: SaCoVLM
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Yongtao Sun, Qianfoshan Hospital
• Original Responsible Party: Lili Cao, Qianfoshan Hospital, Professor
• Current Study Sponsor: Qianfoshan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Qianfoshan Hospital
• Verification Date: January 2023