UMIN-CTR Clinical Trial

Public title

Changes of laryngeal airway patency in anesthetized children with supraglottic airway devices

Acronym

Laryngeal airway patency in anesthetized children with suplaglottic airway devices

Scientific Title

Changes of laryngeal airway patency in anesthetized children with supraglottic airway devices

Scientific Title:Acronym

Laryngeal airway patency in anesthetized children with suplaglottic airway devices

Region

Japan

Condition

anesthetized children with suplaglottic airway devices

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To test an hypothesis that use of sugammadex for reversal of muscle paralysis changes laryngeal airway patency during emergence from general anesthesia in children with suplaglottic airway devices.

Basic objectives2

Others

Basic objectives -Others

To explore whether mechanical parameters such as respiratory sound and respiratory resistance reflect changes of laryngeal airway patency.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

vocal cord angle

Key secondary outcomes

respiratory mechanics parameters such as respiratory sound and respiratory resistance

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

1

years-old

<=

Age-upper limit

6

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Patients who will be anesthetized for inguinal hernia surgery and cryptorchidism surgery
2)Patients whom supraglottic airway devices will be used for
3)Patients who is categorized as American Society of Anesthesia-Physical status 1-3
4)Patients whose weight is over 10 kg at the surgery time
5)Patients whose age is under 6 years old at the surgery time
6)No regard to sex
7)Patients whose parents are given informed
consent about this research

Key exclusion criteria

1)Patients who are at the risk of aspiration
2)Patients whose surgery will be laparoscopic
3)Patients who is under oxypathy
4)Patients who have coagulation abnormality
5)Patients whom supraglottic airway devices don't fit
6)Patients who are under tubal feeding
7)Patients who have the history of larynx disease
8)Patients who take anti-convulsion drugs
9)Patients who have the history of being intubated within one month
10)Patients who are thought to be inadequate by researchers

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Kitamura

Organization

Chiba University Hospital

Division name

Depatment of Anesthesiology

Zip code

Address

inohana1-8-1,Chuou ku ,Chiba City,Chiba Ken

TEL

043-222-7171

Email

yuji.kitamura@chiba-u.jp

Name of contact person

1st name
Middle name
Last name	Shiroh Isono

Organization

Chiba Graduate School of Medicine

Division name

Anesthesiology

Zip code

Address

Inohana 1-8-1,Chuou ku,Chiba City,Chiba ken

TEL

043-222-7171

Homepage URL

Email

shirohisono@yahoo.co.jp

Institute

Chiba University

Institute

Department

Personal name

Organization

Ministry of Education,Culture,Sports,Science and Technology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

11

Month

14

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

30

Day

Last follow-up date

Date of closure to data entry

2018

Year

07

Month

27

Day

Date trial data considered complete

2018

Year

09

Month

03

Day

Date analysis concluded

Other related information

We will endoscopically observe and measure the vocal cord angle of the anesthetized children through a supraglottic airway device(SAD). Primary outcome measure is the change of the vocal cord angle before and after reversal of muscle paralysis by sugammadex and the secondary outcome is characteristics of respiratory sounds and other respiratory mechanics parameters such as tidal volume.

Study protocol
1) A written informed consent is obtained from each of the parent of the child who is scheduled to have a minor surgery in our hospital. Premedication will be used if needed.
2) At operation room, the child will be anesthetized by inhalational anesthetics such as sevoflurane and nitrous oxide and a venous line is secured after appropriate cardiorespiratory monitor such as pulse oximetry is attached to the child. After placement of a SAD, general anesthesia is maintained by appropriate dose of sevoflurane, fentanyl, remifentanil and rocuronium. Mechanical ventilation will be started for maintaining optimal oxygenation and ventilation during the surgery while measuring the respiratory parameters. An endoscope will be inserted through the SAD to measure the vocal cord angle. The respiratory parameters and endoscopic images were displayed on the screen and stored in a computer for later analysis. The measurement will be ceased when the SAD is removed after completion of the surgery.

Registered date

2016

Year

11

Month

29

Day

Last modified on

2018

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028697