Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
anesth2008/01
Study information
Scientific title
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
Acronym
Study hypothesis
We compared the intubation success rate of straight reinforced tracheal tubes emerging from the Airtraq™ laryngoscope (AL) (Prodol Meditec SA, Spain) with the standard polyvinyl chloride (PVC) tracheal tubes in anesthetised and paralysed patients.
Ethics approval
General Hospital of Athens Ethics Committee, approved on 15/06/2008 (ref: 2008/98).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Tracheal intubation
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
1. Rate of successful intubation
2. Impact of AL size, tube size and type on intubation angle
Secondary outcome measures
Factors affecting successful intubation with straight reinforced tubes through the Airtraq™ laryngoscope.
Overall trial start date
01/03/2007
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Increased risk or history of difficult intubation
2. History of gastric aspiration
3. History of relevant drug allergy
Recruitment start date
01/03/2007
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Greece
Trial participating centre
Department of Anaesthesia
Athens
11475
Greece
Funders
Funder type
Hospital/treatment centre
Funder name
General Hospital of Athens, Department of Anaesthesia (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nutri Medica (representative of Prodol Ltd in Greece) provided the Airtraq™ devices free of charge for use in the study
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list