Respiratory Insufficiency Clinical Trial
Official title:
Prospective, Randomized Study in Critically Ill Patients Receiving Endotracheal Intubation: Comparison Between a Conventional Approach and Video Assisted Intubation by the VivaSight™-SL Tube
It has been shown that videolaryngoscopy may be superior to direct laryngoscopy for
endotracheal intubation in intensive care. Recently, an endotracheal tube with an integrated
camera at its tip has been introduced (VivaSight-SL) allowing for direct visual confirmation
of the tube's passage through the vocal cords during intubation.
Patients who are requiring urgent or endotracheal intubation in intensive care are randomized
to receive either a conventional intubation with direct laryngoscopy or to receive intubation
with the VivaSight-SL-Tube. Primary outcome measures are first attempt success rate and
number of attempts to successful intubation.
Background
Airway management in critically ill patients is usually performed by endotracheal intubation
with direct laryngoscopy. [1, 2] However, it has been shown that videolaryngoscopy may be
superior to the conventional approach in intensive care, i. e. the number of attempts to
successful intubation and the rate of accidental esophageal intubation are lower and the
visualization of the vocal chords is improved. [3, 4]
Recently, an endotracheal tube with an integrated camera at its tip has been introduced that
permits a continuous visualization of the tube's insertion into the trachea on a monitor
connected to the camera (VivaSightTM-SL, ETView Ltd., Misgav, Israel) [5]. This tube has been
CE and FDA certified (http://www.etview.com/products/vivasight-sl).
It is possible to observe the passage of the tube through the vocal chords during intubation
and to verify the correct placement by visualization of the tracheal cartilage. This is an
advantage over videolaryngoscopy, in which the camera is mounted on the laryngoscope blade.
For the VivaSightTM-SL tube, a decrease for time to intubation and an increase of first
attempt success has been shown over conventional intubation in a simulator trial. [6]
In this study, the VivaSightTM-SL tube is tested against the conventional approach during
elective and urgent intubations in critically ill patients.
Methods
Study design: randomized, prospective trial
Sample size: n = 54
With a sample size of 54 (randomized 1:1 as 2x 27) a difference of 35% for first attempt
success over conventional intubation may be detected with an α-error of 0,05 and a β-error of
1-0,8.
Duration of study: until sample size reached or 18 months after begin of study
Procedures:
- screening of patients for study inclusion according to inclusion and exclusion criteria
- conventional endotracheal intubation by direct laryngoscopy
- endotracheal intubation with the VivaSightTM-SL tube
study inclusion:
All patients being treated in the Dept. of Intensive Care Medicine receiving percutaneous
tracheotomy due to long term ventilation are screened according to inclusion and exclusion
criteria.
Details of study related procedures:
Intubation:
The Intubation with the VivaSightTM-SL endotracheal tube does not differ from an intubation
with a conventional tube that is done with respect to the standard operating procedure (SOP)
of the Dept. of Intensive Care Medicine. Additionally, the intubation is guided by the camera
mounted on the tip of the tube. During the intubation, vital parameters are monitored with
respect to the underlying disease and patients' therapy is continuously adjusted. According
to the SOP, two physicians are present of which at least one is a fellow or an attending
physician with experience in intensive care medicine. In this trial, intubation is done
exclusively by a fellow or attending physician.
Consent: all patients or their legal surrogate give written informed consent.
Data protection: Data are anonymized.
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