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Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications (C-LMA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01876836
First Posted: June 13, 2013
Last Update Posted: June 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
  Purpose
  1. i-gel
  2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.


Condition Intervention Phase
Bladder Tumour Prostate Hyperplasia Device: i-gel Device: C-LMA Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications

Resource links provided by NLM:


Further study details as provided by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital:

Primary Outcome Measures:
  • Ph MEASUREMENT [ Time Frame: 1 MİNUTE AFTER EXTUBATİON ]
    The ph of the secretions on the airway device will be measurd with a Ph-meter


Secondary Outcome Measures:
  • Bleu dye on the airway device [ Time Frame: 5 min after placenent ]
    The airway device will be examined with fiberoptic endoscope after placement


Other Outcome Measures:
  • Blue dye on airway device [ Time Frame: 1 min after extubation ]
    the airway device will be examined for a precence of blue dye


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: i-gel
i-gel placed after induction
Device: i-gel
i-gel placed after induction
Other Name: supraglottic airway device
Active Comparator: C-LMA
C-LMA placed after induction
Device: C-LMA
placed after induction
Other Name: supraglottic airway device

Detailed Description:

120 ASA I-II adult patients. Patients were randomised into two groups

  1. i-gel
  2. C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • Adult
  • Elective surgery
  • Bladder tumour
  • Prostat hyperplasi

Exclusion Criteria:

  • Emergency surgery
  • Hiatal hernia
  • Gastroeosephageal reflux disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876836


Contacts
Contact: Reyhan Polat, MD +905326734310 reyhanp9@gmail.com

Locations
Turkey
DiskapiYBERH Not yet recruiting
Ankara, Altındağ, Turkey, 06610
Contact: Murat Alper, Prof.    +903125962000    muratalper@hotmail.com   
Principal Investigator: Reyhan Polat, MD         
DiskapiYBERH Not yet recruiting
Ankara, Altındağ, Turkey, 06610
Contact: Reyhan Polat, MD    +905326734310    reyhanp9@gmail.com   
Principal Investigator: Reyhan Polat, MD         
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
Principal Investigator: Reyhan Polat, MD Diskapi Yildirim Beyazit Education and Research Hospital
  More Information

Responsible Party: Reyhan Polat, Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01876836     History of Changes
First Submitted: June 10, 2013
First Posted: June 13, 2013
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital:
i-gel
C-LMA
gastroeosephageal reflux
sore troat

Additional relevant MeSH terms:
Hyperplasia
Postoperative Complications
Urinary Bladder Neoplasms
Prostatic Hyperplasia
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases
Genital Diseases, Male