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Cuff Pressure in Infants

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. Identifier: NCT03088761
Recruitment Status : Unknown
Verified April 2017 by Kemal Tolga Saracoglu, Istanbul Science University.
Recruitment status was:  Not yet recruiting
First Posted : March 23, 2017
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Kemal Tolga Saracoglu, Istanbul Science University

Brief Summary:
The changes in the cuff pressure in the absence of nitrous oxide are less clear.In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.

Condition or disease Intervention/treatment
Myelomeningocele Prone Position Device: cuffed tracheal tube

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in the Cuff Pressure in Infants in the Absence of Nitrous Oxide
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
cuffed tube pressure group

The pressures of cuffed tracheal tubes will be monitored simultaneously with a cuff manometer and pressure transducer. The measurements will be observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff will be deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery will be recorded.

The baseline cuff pressure will be assessed in the supine position after which time a second measurement will be made in the prone position. A blind investigator will check and record the findings of cuffed tracheal tube.

Device: cuffed tracheal tube
the changes in cuff pressure will be determined using a cuff manometer

Primary Outcome Measures :
  1. the change in cuff pressure [ Time Frame: four months ]
    the change in cuff pressure will be recorded during prone position

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
1-30 days old infants undergoing meningomyelocele repair

Inclusion Criteria:

  • male and female infants undergoing meningomyelocele repair

Exclusion Criteria:

  • tracheal intubation with uncuffed tube, the use of N2O during anesthesia, accompanying disease like hydrocephalus

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 identifier (NCT number): NCT03088761

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Contact: Kemal T Saracoglu, MD +905385478620
Contact: Aten Saracoglu, MD +905377810144

Sponsors and Collaborators
Istanbul Science University
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Principal Investigator: Kemal T Saracoglu Istanbul Science University School of Medicine
Publications of Results:

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Responsible Party: Kemal Tolga Saracoglu, Associate Professor MD, Istanbul Science University Identifier: NCT03088761    
Other Study ID Numbers: 44140529
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kemal Tolga Saracoglu, Istanbul Science University:
tracheal tube
cuff pressure
Additional relevant MeSH terms:
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Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Spinal Dysraphism