Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03759561 |
| Other study ID # |
VL_FOB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 14, 2018 |
| Est. completion date |
January 18, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Seoul National University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In patients with suspected cervical spine injury, cervical immobilization, such as manual
in-line stabilization or cervical collar has been adopted to prevent further neurologic
injury due to cervical motion. In these patients, tracheal intubation with direct
laryngoscopy is often challenging due to limited mouth opening, neck flexion, and head
extension. In this situation, videolaryngoscope and fiberoptic bronchoscope have been used
for tracheal intubation in such patients. In this study, the initial success rate of tracheal
intubation and intubation time between the videolaryngoscope and fiberoptic bronchoscope will
be compared.
Description:
Patients entered the operating room without premedication. Airway-related parameters
(modified Mallampati score, interincisior gap, thyromental distance, sternomental distance,
and retrognathia) were evaluated in the sitting position. After changing to the supine
position, thyromental height was measured and patients were monitored with
electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and processed
electroencephalography. Cotton towels were placed below the patient's head for horizontal
alignment of the external auditory meatus and the suprasternal notch. After sufficient
preoxygenation for > 3 min, total intravenous anaesthesia was induced using a
target-controlled infusion of propofol and remifentanil (effect site concentration: 4 µg/mL
for propofol and 4 ng/mL for remifentanil). After confirming loss of consciousness,
rocuronium (0.6-0.8 mg/kg) was administered to facilitate tracheal intubation, and mask
ventilation was conducted. During mask ventilation, its difficulty was assessed and the use
of the oropharyngeal airway was recorded. For invasive blood pressure measurement, a 20-gauge
catheter was placed on the patient's radial artery. Thereafter, the patient's head was placed
in the neutral position and an cervical collar was applied to minimise neck movement during
intubation.
About 90 s after administrating rocuronium, tracheal intubation was attempted by one of five
attending anaesthesiologists with a collective history of more than 30 successful
videolaryngoscopic and fiberscopic intubations. A reinforced tracheal tube was used in both
groups. Orotracheal intubation was performed using a videolaryngoscope with a disposable
Macintosh-typed blade and a malleable stylet in the videolaryngoscope group, and using a
flexible fiberscope with an eyepiece in the fiberscope group. A tracheal tube was mounted on
the stylet and flexible fiberscope in the videolaryngoscope and fiberscope groups,
respectively. The stylet was angulated about 60° at the proximal margin of the cuff. Tracheal
intubation was initially attempted without any assistance, including airway manoeuvres and
devices. If additional airway manoeuvres including external laryngeal manipulation (ELM), jaw
thrust, and tongue traction were required during intubation attempts, they were performed by
an assistant and noted. After confirming the glottis, the percentage of glottic opening
(POGO) score was recorded just before inserting the tracheal tube into the trachea. The
tracheal tube was inserted into the trachea after removing the stylet and confirming the
carina in the videolaryngoscope and fiberscope groups, respectively. Successful intubation
was confirmed by waveform capnography. The time from oral insertion of the intubation device
to obtainment of the glottis view (glottis visualisation time), to placement of the tracheal
tube (tube placement time), and to detection of the waveform capnograph (capnograph detection
time) were also measured.
A maximum of three intubation attempts were allowed for the same anaesthesiologist, with a
180-s time limit for each attempt. If the peripheral oxygen saturation (SpO2) decreased to
below 90% during the intubation attempt, the attempt was considered to have failed, and
rescue mask ventilation was conducted until SpO2 reached 100%. Cases where tracheal
intubation was unsuccessful on all three attempts were recorded as intubation failure.
After surgery, intubation-related airway complications were investigated. Airway injuries
(blood in the oral cavity, blood staining on the tracheal tube, gum bleeding, and dental
trauma) were assessed at the end of surgery. In addition, hoarseness and sore throat were
evaluated at 1 h and 24 h after surgery. The severity of sore throat was measured using a
numeric rating scale (NRS; 0: no pain, 10: worst pain imaginable).
Mean blood pressure (MBP), heart rate (HR), SpO2, and bispectral index (BIS) were recorded
just before the intubation attempt and at 1 min after successful intubation. Other
perioperative data (demographic, anaesthetic, and surgical data) were collected from
electronic medical records.
