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Main
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Note: This record shows only the 20 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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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN50146191 |
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Date of registration:
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30/03/2009 |
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Primary sponsor: |
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Public title:
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Comparison of the standard polyvinyl chloride tracheal tubes and the straight reinforced tracheal tubes for tracheal intubation through different sizes of the Airtraq™ laryngoscope in anesthetised and paralysed patients
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Scientific title:
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Comparison of the standard Polyvinyl chloride tracheal tubes and the straight reinforced tracheal tubes for tracheal intubation through different sizes of the Airtraq™ laryngoscope in anesthetised and paralysed patients; a prospective randomised study |
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Date of first enrolment:
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Mar 1 2007 |
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Target sample size:
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300 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN50146191 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
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Countries of recruitment
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Greece
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Contacts
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Name:
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Vasilios
Dimitriou |
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Address:
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Department of Anaesthesia
General Hospital of Athens
154, Mesogion Avenue
11475
Athens
Greece |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Both males and females, aged 22-75 years
2. American Society of Anesthesiologists (ASA) physical status I-III
3. Scheduled for surgical procedures requiring tracheal intubation
Exclusion criteria: 1. Increased risk or history of difficult intubation
2. History of gastric aspiration
3. History of relevant drug allergy
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Tracheal intubation
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Intervention(s)
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The study was conducted in the General Hospital of Athens from March 2007 to January 2009. In total, 347 participants were enrolled into the study.
The participants were randomly allocated (using sealed envelopes) to the following three arms:
1. Intubation with PVC tracheal tubes (PVCT)
2. Intubation with standard wire-reinforced tracheal tubes (RFT)
3. Intubation with silicone wire-reinforced tubes (RFST)
Two sizes of AL were available (7.0-8.5 ID and 6.0-7.5 ID). The sizes of AL and tracheal tube were chosen according to the weight, height and sex of each patient.
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Primary Outcome(s)
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1. Rate of successful intubation
2. Impact of AL size, tube size and type on intubation angle
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Secondary Outcome(s)
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Factors affecting successful intubation with straight reinforced tubes through the Airtraq™ laryngoscope.
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Secondary ID(s)
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anesth2008/01
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Source(s) of Monetary Support
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1. General Hospital of Athens, Department of Anaesthesia (Greece)
2. Nutri Medica (representative of Prodol Ltd in Greece) provided the Airtraq™ devices free of charge for use in the study
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