Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04628611 |
Other study ID # |
IORG000381 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2016 |
Est. completion date |
February 1, 2020 |
Study information
Verified date |
November 2020 |
Source |
National Cancer Institute, Egypt |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a randomized control study where adult patients had been divided randomly into two
equal groups using video laryngoscope in group (V) and flexible intubating laryngoscope in
group (F)
Description:
Routine pre-operative assessment including history taking, clinical examination, and
laboratory tests. Patients were admitted to the operating room with a small 20G IV cannula
after applying inclusion & exclusion criteria and airway assessment by applying El Ganzuri
multivariate risk index for difficult intubation which include assessment of the following :
inter-incisor gap, Mallampati classification, head &neck movement, buck teeth prognathism,
thyromental distance, body weight and history of difficult intubation.
Operating room was prepared using :
Difficult airway cart that includes different size oral airways, endotracheal tubes,
different sizes face masks & laryngeal airway masks Suction apparatus to be ready for use
Video laryngoscopy The flexible intubating laryngoscopy with the tube mounted over the
fiberscope before the procedure.
Standard monitoring devices were applied including ECG, non invasive blood pressure. pulse
oximetry and capnography after intubation Patients were then pre-oxygenated via face mask for
three minutes and using 0.01 mic/kg atropine then general anesthesia is induced using
fentanyl 1-2 mic/kg followed by propofol 2 mg/kg and esmeron 0.5 mg/kg.
The patient is mechanically ventilated using face mask until full relaxation is established
after 3-5 minutes. The intubation is done using video laryngoscope in group (v) or using
flexible intubating laryngoscopy in group (f) In the first group (v) The video laryngoscope
was introduced with the patient appropriately positioned, the operator used the left hand to
introduce the video laryngoscope into the midline of the Oropharynx and gently advances until
the blade tip pass the posterior portion of the tongue. Using video visualization, the ETT
was then advanced on a smooth curve through the glottis and intubation proceeds. Viewing the
entire insertion step on the video screen allows the operator to quickly become facile with
the motion of gently rotating or angling the tube using the right hand to redirect as
necessary.
In the second group(f) patients positioned supine with the operator standing at the head of
the bed. Simple chin lift and jaw thrust may improve the view through the flexible
laryngoscopy and also help to prevent airway obstruction. The endotracheal tube should be
lubricant to facilitate its subsequent advancement into the trachea. Once the endotracheal
tube is in place, the scope is removed, and the patient is ventilated. Flexible intubating
laryngoscopy is often performed with the operator looking through the eyepiece. However,
connecting the flexible laryngoscopy to a monitor is often advantageous.
After collecting demographic data of the patient (age, sex, body mass index & ASA) The
following parameters will be measured :
Intubation time, Hemodynamic parameters, success rate and number of attempts & incidence of
complications.