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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019968
Receipt No. 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

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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
Institute bhopal memorial hospital and research center
Institute
Department

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
URL(English) https://upload.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


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