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

NCT ID: NCT05338827

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-08-01

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.

Conditions

Laparoscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Polyvinyl Chloride Tube group

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Wire-Reinforced Tube group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongtao Sun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongtao Sun, doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Yongtao Sun

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongtao Sun, doctor

Role: CONTACT

sunyongtao1979@163.com

18660795201

Facility Contacts

Yongtao Sun, doctor

Role: primary

sunyongtao1979@163.com

18660795201

References

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.

Reference Type: DERIVED

PMID: 36517088 (View on PubMed)

Other Identifiers

SaCoVLM

Identifier Type: -

Identifier Source: org_study_id