NCT04719767

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

January 6, 2021

Last Update Submit

January 21, 2021

Conditions

General AnesthesiaLaryngeal MaskEndotracheal IntubationSurgery

Outcome Measures

Primary Outcomes (1)

  • Intubation time (second)

    Compare the time of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions

    intraoperative

Secondary Outcomes (4)

  • Success rate of the endotracheal intubation (%)

    intraoperative

  • Displacement rate of the laryngeal mask airway (%)

    Immediately after operation

  • Incidence of oropharyngeal pain as assessed by the VAS

    postoperative one day

  • Incidence and severity of hoarseness as assessed by a numerical scale

    postoperative one day

Study Arms (2)

visual

EXPERIMENTAL

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

Non-visual

NO INTERVENTION

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.

Interventions

visual laryngeal maskDEVICE

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.

visual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yuguang Huang, M.D.

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Yahong Gong, M.D.

CONTACT

86-13611273163yh2087@163.com

Xia Ruan, M.D.

CONTACT

86-13691512741sheyaruan@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patients, surgeons and the ones who collect data will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor of the Department of Anesthesiology

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 30, 2022

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share