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 |
EFFICIENT AIRWAY DEVICE FOR ELECTIVE LAPAROSCOPIC SURGERIES: I-GEL VERSUS ENDOTRACHEAL TUBE. A RANDOMISED CLINICAL TRIAL
Supra Glottic Airway Device for Laparoscopic Surgeries
EFFICIENT AIRWAY DEVICE FOR ELECTIVE LAPAROSCOPIC SURGERIES: I-GEL VERSUS ENDOTRACHEAL TUBE. A RANDOMISED CLINICAL TRIAL
Supra Glottic Airway Device for Laparoscopic Surgeries
Asia(except Japan) |
patients posted for laparoscopic cholecsytectomy
Anesthesiology |
Others
NO
1. Comparison of Hemodynamic responses during insertion of the airway device
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.
Confirmatory
Others
Not applicable
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
Airway insertion, insertion and gastric tube insertion were easier with I-Gel.
Endotracheal tube provided higher oropharyngeal seal pressures
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
ENDOTRACHEAL TUBE(CUFFED)
I-GEL(SAD)
20 | years-old | < |
50 | years-old | > |
Male and Female
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
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
200
1st name | |
Middle name | |
Last name | DR RAJNISH K JAIN |
BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTER
ANESTHESIOLOGY AND CRITICAL CARE
DEPT OF ANESTHESIOLOGY AND CRITICAL CARE,BMHRC, BHOPAL462038
+91-9425012102
rajnishkjain@gmail.com
1st name | |
Middle name | |
Last name | DR N SIVA KRISHNA |
VELAMMAL MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
ANESTHESIOLOGY AND CRITICAL CARE
FLAT F3, PENGUIN APARTMENTS, 8/2ND CROSS STREET, LAKE AREA,MADURAI 625107
+91-7708331614
krissiva@live.in
bhopal memorial hospital and research center
BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTER
Self funding
INDIA
NO
BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTER(BHOPAL-INDIA)
2016 | Year | 01 | Month | 17 | Day |
Unpublished
Completed
2013 | Year | 01 | Month | 10 | Day |
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 04 | Month | 30 | Day |
2015 | Year | 11 | Month | 28 | Day |
2015 | Year | 11 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022998
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