Condition category
Surgery
Date applied
09/03/2009
Date assigned
30/03/2009
Last edited
30/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vasilios Dimitriou

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

General Hospital of Athens (Greece)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes