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

NCT05338827 | Unknown

• 1 other identifier: SaCoVLM
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The total success rate of tracheal intubation

  defined as the cumulative third-attempt intubation success rate

  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 Outcomes (7)

• Successful insertion rate on the first attempt

  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 tracheal intubation

  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.

• Site of first contact of tracheal intubation

  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.

• Adjustment action for tracheal intubation

  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.

• Haemodynamic fluctuation

  It will take up to half hour or 1 hour.

Study Arms (2)

Polyvinyl Chloride Tube group

EXPERIMENTAL

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

Wire-Reinforced Tube group

EXPERIMENTAL

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

Interventions

Polyvinyl Chloride Tube group PROCEDURE

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.

Polyvinyl Chloride Tube group

Wire-Reinforced Tube group PROCEDURE

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.

Wire-Reinforced Tube group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Yongtao Sun

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (1)

• Gao Z, Guo Y, Gao X, Wang W, Zhang M, Liu MJ, Chen L, Liu Y, Zhang X, Sun Y, Wang Y. Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study. BMJ Open. 2022 Dec 14;12(12):e066084. doi: 10.1136/bmjopen-2022-066084.

  PMID: 36517088 DERIVED

Study Officials

• Yongtao Sun, doctor

  Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongtao Sun, doctor

CONTACT

18660795201; sunyongtao1979@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)