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

ISRCTN	ISRCTN50146191
DOI	https://doi.org/10.1186/ISRCTN50146191
Secondary identifying numbers	anesth2008/01

Submission date: 09/03/2009
Registration date: 30/03/2009
Last edited: 30/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Vasilios Dimitriou
Scientific

Department of Anaesthesia
General Hospital of Athens
154, Mesogion Avenue
Athens
11475
Greece

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	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(s)	General Hospital of Athens Ethics Committee, approved on 15/06/2008 (ref: 2008/98).
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2007
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	300
Key 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
Key exclusion criteria	1. Increased risk or history of difficult intubation 2. History of gastric aspiration 3. History of relevant drug allergy
Date of first enrolment	01/03/2007
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

Greece

Study participating centre

Department of Anaesthesia

Athens
11475
Greece

Sponsor information

General Hospital of Athens (Greece)
Hospital/treatment centre

c/o Prof Vasilios Dimitriou
Department of Anaesthesia
154, Mesogion Avenue
Athens
11475
Greece

Funders

Funder type

Hospital/treatment centre

General Hospital of Athens, Department of Anaesthesia (Greece)

No information available

Nutri Medica (representative of Prodol Ltd in Greece) provided the Airtraq™ devices free of charge for use in the study

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan