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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT02603094 |
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Date of registration:
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10/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Gastric pH in Intubated Children - Part Two
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Scientific title:
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Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02603094 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Achim J Schmitz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Children's Hospital, Zurich, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
age > 1 / < 16 years ASA class l or ll elective surgery requiring general anaesthesia
using tracheal intubation
Exclusion Criteria:
disease or dysfunction of gastrointestinal tract chronic diseases or conditions not
compatible with ASA class l or ll
Age minimum:
1 Year
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Preoperative Fasting
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Intervention(s)
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Procedure: clear fluid ingestion
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Primary Outcome(s)
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gastric pH
[Time Frame: within 10 min after tracheal intubation]
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Secondary Outcome(s)
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subjective feeling of hunger/thirst
[Time Frame: baseline]
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Postoperative Nausea and Vomiting (PONV) in recovery unit
[Time Frame: recovery period, on the average within 90 minutes after end of anaesthesia]
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Behaviour during recovery period
[Time Frame: recovery period, on the average within 90 minutes after end of anaesthesia]
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gastric aspirate volume
[Time Frame: within 10 min after tracheal intubation]
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Nurse's Impression of patient's satisfactory
[Time Frame: baseline]
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Behaviour during anaesthesia induction
[Time Frame: on the average within 20 minutes after arrival of patient in operating theatre]
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blood Ketone measurement
[Time Frame: intraoperative]
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Secondary ID(s)
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KEK-ZH Nr. 2011-0034 Amend3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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