UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019968
Receipt number R000022998
Scientific Title EFFICIENT AIRWAY DEVICE FOR ELECTIVE LAPAROSCOPIC SURGERIES: I-GEL VERSUS ENDOTRACHEAL TUBE. A RANDOMISED CLINICAL TRIAL
Date of disclosure of the study information 2016/01/17
Last modified on 2015/11/28 04:50:29

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Basic information

Public title

EFFICIENT AIRWAY DEVICE FOR ELECTIVE LAPAROSCOPIC SURGERIES: I-GEL VERSUS ENDOTRACHEAL TUBE. A RANDOMISED CLINICAL TRIAL

Acronym

Supra Glottic Airway Device for Laparoscopic Surgeries

Scientific Title

EFFICIENT AIRWAY DEVICE FOR ELECTIVE LAPAROSCOPIC SURGERIES: I-GEL VERSUS ENDOTRACHEAL TUBE. A RANDOMISED CLINICAL TRIAL

Scientific Title:Acronym

Supra Glottic Airway Device for Laparoscopic Surgeries

Region

Asia(except Japan)


Condition

Condition

patients posted for laparoscopic cholecsytectomy

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. Comparison of Hemodynamic responses during insertion of the airway device

Basic objectives2

Others

Basic objectives -Others

2.Ease of insertion of airway device (in terms of number of attempts & time taken to secure the airway)
3.Ease of gastric tube insertion(in terms of number of attempts & number of maneuvers)
4.Efficacy of perilaryngeal seal(by calculating Maximum Oropharyngeal Seal Pressure)
5.Adequacy of ventilation ( in terms of SPO2 & ETCo2)
6.Incidence of gastric content aspiration.
7.Pharyngo-laryngeal morbidity.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The ETT group had higher heart rate at 1 minute, 3 minutes and 5 minutes after insertion of airway device. ETT group had higher mean arterial pressure values starting from 1 minute after airway insertion till 5 minutes

Key secondary outcomes

Airway insertion, insertion and gastric tube insertion were easier with I-Gel.
Endotracheal tube provided higher oropharyngeal seal pressures


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

ENDOTRACHEAL TUBE(CUFFED)

Interventions/Control_2

I-GEL(SAD)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

1.ASA Grade 1 & 2 patients posted for elective laparoscopic surgeries
2.Patients aged between 20-50yrs
3.BMI less <30kg/m2
4.Surgery of <3hrs duration
5.Surgery in supine/ lithotomy / trendelenberg posture
6.Mallampati grading 1 to 2

Key exclusion criteria

1.ASA grade >3
2.Age <20yrs or >50yrs
3.BMI >30kg/m2
4.Mallampati grade 3 & 4
5.History of hiatus hernia, GERD
6.Surgery involving positioning of patient in other than supine/ lithotomy
7.Patients having pathology of neck ,URTI & predicted difficult intubation
8.History of cardiopulmonary disease & neurological disease
9.Duration of surgery >3hrs
10.Non-fasted patients & all emergency surgical procedures
11.Patients refusing to participate in the study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name DR RAJNISH K JAIN

Organization

BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTER

Division name

ANESTHESIOLOGY AND CRITICAL CARE

Zip code


Address

DEPT OF ANESTHESIOLOGY AND CRITICAL CARE,BMHRC, BHOPAL462038

TEL

+91-9425012102

Email

rajnishkjain@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name DR N SIVA KRISHNA

Organization

VELAMMAL MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE

Division name

ANESTHESIOLOGY AND CRITICAL CARE

Zip code


Address

FLAT F3, PENGUIN APARTMENTS, 8/2ND CROSS STREET, LAKE AREA,MADURAI 625107

TEL

+91-7708331614

Homepage URL


Email

krissiva@live.in


Sponsor or person

Institute

bhopal memorial hospital and research center

Institute

Department

Personal name



Funding Source

Organization

BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTER

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

INDIA


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTER(BHOPAL-INDIA)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2014 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 28 Day

Last modified on

2015 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022998


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name