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CompletedNCT05091281Updated Jan 12, 2022

Macintosh Versus GlideScope Versus C-MAC for Double Lumen Endotracheal Intubation

An interventional study of Intubation of the double lumen tube by Macintoch laryngoscope and Intubation of the double lumen tube by Glidescope videolaryngoscope in Thoracic, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by Tanta University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Thoracic

Keywords

  • Macintosh
  • laryngoscope
  • GlideScope
  • C-MAC
  • videolaryngoscope
  • double lumen tube
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I-II
  • BMI \< 35 kg/m2
  • Mallampati score of 1 or 2

Exclusion criteria

Exclusion Criteria:

  • Patients with risk of gastric aspiration
  • Patients with risk of gastric aspiration
  • Presence of any predictors of difficult intubation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
105 participants (actual)

Study arms

  • Active comparator
    Group I

    After induction of anesthesia intubation was done by Macintosh laryngoscope

    Device: Intubation of the double lumen tube by Macintoch laryngoscope

  • Active comparator
    Group II

    After induction of anesthesia intubation was done by GlideScope®videolaryngoscope

    Device: Intubation of the double lumen tube by Glidescope videolaryngoscope

  • Active comparator
    Group III

    After induction of anesthesia intubation was done byC-MAC®(D) videolaryngoscope

    Device: Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope

Interventions

  • DeviceIntubation of the double lumen tube by Macintoch laryngoscope

    After induction of anesthesia insertion of the double lumen tube was done by Macintosh laryngoscope

  • DeviceIntubation of the double lumen tube by Glidescope videolaryngoscope

    After induction of anesthesia insertion of the double lumen tube was done by GlideScope® videolaryngoscope

  • DeviceIntubation of the double lumen tube by C-MAC®(D) videolaryngoscope

    After induction of anesthesia insertion of the double lumen tube was done by C-MAC®(D) videolaryngoscope

06

What researchers measure

Primary outcomes

  1. Double lumen tube insertion times in seconds

    Double lumen tube insertion times by the three types of laryngoscopes were recorded

    Time frame: 2 minutes

  2. first-pass success rates

    Double lumen tube insertion first-pass success ratesby the three types of laryngoscopes were recorded

    Time frame: 2 minutes

Secondary outcomes

  1. Blood pressure measurement in mm Hg

    During intubation and then every 15 minutes in mm Hg

    Time frame: 150 minutes

  2. Heart rate measurement in beat/minute

    During intubation and then every 15 minutes in beat/minute

    Time frame: 150 minutes

07

Study locations

1 site
  • Mona Mohamed Mogahed
    Tanta, Elgharbia, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05091281
Lead sponsor
Tanta University
Responsible party
Mona Mohamed Mogahed (Associate professor, Tanta University) — Principal investigator
First posted
Oct 25, 2021
Start date
Nov 5, 2021
Primary completion
Jan 10, 2022
Completion
Jan 10, 2022
Last update
Jan 12, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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