Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in General Anesthesia

Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in Non-head and Neck Surgery Under General Anesthesia

To study the advantages of visual laryngeal mask combined with endotracheal intubation in general anesthesia surgery, we compared intubation time, intubation times and intubation success rate of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions, at the same time, the laryngeal mask displacement rate, volume of secretion in airway, the incidence of laryngeal spasm, the incidence and severity of postoperative oropharyngeal pain were also compared between two groups.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation; Surgery; General Anesthesia; Laryngeal Mask
• Intervention / Treatment: Device: visual laryngeal mask

Detailed Description

After entering the operating room, the patient received routine general anaesthesia monitoring, and anesthesia induction was conducted after three-party verification. Propofol (plasma target-controlled concentration: 3.5ug/ mL), midazolam (0.05mg/kg), fentanyl (2ug/kg) and rocuronium (0.6mg/kg) were used to induce the drugs.

After anesthesia induction, visual laryngeal mask airway was placed in the visual group and endotracheal intubation was guided under visual conditions. In the non-visual group, after judging the position of laryngeal mask by clinical experience, endotracheal intubation was inserted blindly. Selection of laryngeal mask airway (LMA) model based on: the ideal body weight of the patient, 3 was selected for the body weight of 30-50kg, 4 for the body weight of 50-70kg and 5 for the body weight > 70kg. The endotracheal tube intubation time, intubation times and intubation success rate of the two groups were recorded.

During the operation, propofol and fentanyl are used for anesthesia maintenance, and the anesthesiologist adjusts the anesthesia depth according to his/her own experience. Ten minutes before the end of the operation, endotracheal intubation was removed and the laryngeal mask airway was retained. The displacement rate of the laryngeal mask airway, the volume of secretion in airway and the incidence of laryngeal spasm were compared between the two groups.

After the surgery, the residual muscle relaxation was antagonized, and the laryngeal mask was removed after the patient regained consciousness and reached the extubation criteria. The hemodynamic parameters and the severity of cough during laryngeal mask airway removal were recorded. The incidence and severity of oropharyngeal pain, oropharyngeal numbness, hoarseness, nausea, and vomiting were assessed immediately after the patient woke up and was followed up before leaving the recovery room and on the first day after surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xia Ruan, M.D.; Phone Number: 86-13691512741; Email: sheyaruan@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18-70
• American Society of Anesthesiologist physical status (ASA) Ⅰ-II
• Undergoing non-head and neck surgery under general anesthesia with endotracheal intubation
• Sign the informed consent voluntarily;

Exclusion Criteria:

• Not willing to participate in the study or not able to sign the informed consent
• American Society of Anesthesiologist physical status (ASA) Ⅲ-Ⅳ
• Weight <30kg or BMI>40 kg/m2
• High risk of reflux aspiration
• Combined with severe respiratory disease
• Combined oropharyngeal lesions affect the laryngeal mask insertion
• Oropharyngeal pain in the last two weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: visual; In the visual group, a visual laryngeal mask was placed and endotracheal intubation was guided under visual conditions. The endotracheal tube was removed 10 minutes before the end of the operation, and the laryngeal mask was retained.	Device: visual laryngeal mask; After anesthesia induction, visual laryngeal mask airway was placed in the visual group and tracheal intubation was guided under visual conditions. In the non-visual group, laryngeal mask airway was inserted, after clinical judgment of good counterpoint of the laryngeal mask, endotracheal intubation was inserted blindly through LMA. Selection of laryngeal mask airway (LMA) model: the ideal body weight of the patient was calculated.
NO_INTERVENTION: Non-visual; In the non-visual group, laryngeal mask airway was inserted. After clinical judgment of good counterpoint, endotracheal intubation was inserted blindly through LMA. Endotracheal intubation was removed 10 minutes before the end of the operation, and the laryngeal mask airway was retained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time (second)	Compare the time of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of the endotracheal intubation (%)	Compare success rate of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions	intraoperative
Displacement rate of the laryngeal mask airway (%)	Compare displacement rate of the laryngeal mask airway after tracheal intubation removal under visual and non-visual conditions	Immediately after operation
Incidence of oropharyngeal pain as assessed by the VAS	On the first day after operation, the patients were asked to score the oropharyngeal pain. Based on the distribution of pain VAS scores in postsurgical patients, the following cut points on the pain VAS have been recommended. No pain (0 -4 mm) Mild pain (5-44 mm) Moderate pain (45-74 mm) Severe pain (75-100 mm) The significance of the Visual Analog Scale.	postoperative one day
Incidence and severity of hoarseness as assessed by a numerical scale	Normal = 1, weakened or hoarse = 2, unable to pronounce = 3	postoperative one day

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Yuguang Huang, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PUMCH-rx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No