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

NCT ID: NCT04719767

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-06-30

Brief Summary

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.

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.

Conditions

General Anesthesia; Laryngeal Mask; Endotracheal Intubation; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

visual laryngeal mask

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xia Ruan

Attending doctor of the Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuguang Huang, M.D.

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Central Contacts

Yahong Gong, M.D.

Role: CONTACT

yh2087@163.com

86-13611273163

Xia Ruan, M.D.

Role: CONTACT

sheyaruan@sina.com

86-13691512741

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PUMCH-rx

Identifier Type: -

Identifier Source: org_study_id