Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05091281 |
| Other study ID # |
34776/7/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2021 |
| Est. completion date |
January 10, 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The double lumen endotracheal tube (DLT) is the most widely-used device for single lung
ventilation in current thoracic anesthesia practice. In recent years, the routine application
of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless
there are few studies of the use of the videolaryngoscope for DLT. The authors wondered
whether there were benefits to using the videolaryngoscope for DLT placement in patients with
predicted normal airways. Therefore, this study was designed to compare the performances of
the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT
intubation.
Description:
Patients randomly assigned into Macintosh group, GlideScope (Verathon Medical, Bothwell, UT,
USA) group, or CMAC(D) (Karl Storz GmbHand Co.KG, Tuttlingen, Germany) group. This will be
done using a closed envelope technique using a computer-generated block randomization method.
Before the study, the computerized randomization will be performed and the allocation results
will be placed in individual numbered and sealed envelopes. Patients remained blinded about
their intubation technique until post-operative assessment was completed. The researcher
responsible for recruitment will be blinded to the allocation result. After a patient will be
consented for the study, allocation will be revealed. All endotracheal intubations will be
performed by fthe same anesthesiologist with 10 years' working experience skilled in
videolaryngoscopy. Left-side or right-side 32Fr/35Fr Mallinckrodt™ DLTs (Mallinckrodt
Medical, Athlone, Ireland) will be selected for female patients and 35Fr/37Fr DLTs for male
patients depending on whether their heights were below or above 155 cm for females and 165 cm
for males. If the operation side will be the left, right-side DLT will be used; otherwise,
the left-side DLT will be used. To facilitate intubation, the distal 10-12 cm concavity of
the DLT (with the stylet in situ) will be molded along the blade convexity in each group. The
tracheal and the bronchial cuffs of the DLT tubes will be lubricated with sterile Surgilube.
No premedication will be given before induction. Standard monitoring prior to induction
included ECG, invasive arterial blood pressure, SpO2, and end-tidal carbon dioxide. After
pre-oxygenation with 100% oxygen, anesthesia will be induced with intravenous midazolam 0.05
mg. kg- 1 , propofol 1.5 mg. kg- 1 , fentanyl 5 μg. kg- 1 , and rocuronium 0.6 mg. kg- 1 .
Two minutes after rocuronium administration, DLT intubation will be performed using the
allocated laryngoscope. The DLT will be inserted with the distal concavity facing anteriorly
until the bronchial lumen cuff passed the vocal cords. The stylet will be then removed, and
rotation will be performed while tube will be advanced. The left DLT rotated 90°
counter-clockwise, and the right DLT will be rotated 90° clockwise to enter the respective
mainstem bronchus. The number of intubation attempts, ease of laryngoscopy insertion, Quality
of view, Assist maneuvers, Intubation difficulty will be recorded. Hemodynamic changes will
be monitored during induction. If systolic blood pressure fell below 80 mmHg, ephedrine 5 mg
will be administrated intravenously. Atropine 0.5 mg will be given for heart rate below 50
beats per minute. After the tip of the DLT was located in the targeted bronchus, the tracheal
cuff will be inflated and ventilation of the lungs started. Fiberoptic bronchoscopic
assessment of adequate bronchial cuff placement will be followed by DLT placement. DLT
insertion time will be defined as from the time the laryngoscope passed the patient's lips
until three complete end-tidal carbon dioxide cycles were displayed on the monitor.
Intubation success rate at the first attempt will be recorded by the same observer. The
difficulty of DLT insertion and delivery will be assessed by the operator, using NRS ranging
from 0 to 10. The NRS results will be grouped as 0 = none, 1-3 = mild, 4-6 = moderate, and
7-10 = severe. C/L degrees were classified as four degrees (I, IIA, IIB, and III) and will be
assessed by the same operator. If the degree will be not class I, external laryngeal pressure
will be provided by an assistant. Time required to successful intubation. Intubation time is
defined as the time taken for insertion of the blade between the teeth till the tracheal tube
cuffٴ passed through the vocal cords. Failure of intubation was defined as any intubation
attempt of >120 s or inability to intubate. Number of intubation attempts, Ease of
laryngoscope insertion, Quality of view by Cormack and Lehane grade . Assist maneuvers.
Intubation difficult score indicates the degree of difficulty of intubation using 7
parameters (0=easy intubation, 0 ˂IDS≤5 =slight difficulty, 5 < IDS =moderate to major
diffculty, IDS= ∞ impossible intubation) . The time taken for fiberoptic bronchoscopy was
defined as the time from endobronchial intubation to placement confirmation using fiberoptic
bronchoscopy. The operators examined blade surfaces for blood after removal. Hemodynamic
parameters (mean arterial blood pressure and heart rate) will be recorded 10 min before
induction and 1, 3, and 5 min after intubation. After the assessment by fiberoptic
bronchoscopy, the oral cavity, pharynx, larynx and teeth will be examined for signs of
laceration or bleeding by an independent investigator who will be unaware of the type of
laryngoscope used. One day after surgery, an independent investigator will interview patients
to assess the presence of sore throat and hoarseness of voice.
