Clinical trial NCT05338827: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: SaCO Video Laryngeal Mask Airway
intubating laryngeal mask airway
laryngeal mask airway
supraglottic airway devices
endotracheal intubation
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: The total success rate of tracheal intubation
timeFrame: 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:
measure: Successful insertion rate on the first attempt
timeFrame: 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.
measure: Time of tracheal intubation
timeFrame: 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.
measure: Site of first contact of tracheal intubation
timeFrame: 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.
measure: Adjustment action for tracheal intubation
timeFrame: 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.
measure: Haemodynamic fluctuation
timeFrame: It will take up to half hour or 1 hour.
measure: Incidence of trauma as evidenced by blood
timeFrame: It will take up to half hour or 1 hour.
measure: Incidence rate of postoperative sore throat, hoarseness and dysphagia at 24 hours after the surgery
timeFrame: one day after the surgery.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yongtao Sun
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
name: Yongtao Sun, doctor
role: PRINCIPAL_INVESTIGATOR
References: