AzTrials
AzTrials

ThoracicNCT05091281

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

A study testing Intubation of the double lumen tube by Macintoch laryngoscope, Intubation of the double lumen tube by Glidescope videolaryngoscope and Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope in people with Thoracic, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Thoracic
What is being tested?
Intubation of the double lumen tube by Macintoch laryngoscope, Intubation of the double lumen tube by Glidescope videolaryngoscope and Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteEgypt
Study dates
5 Nov 2021to 10 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mona Mohamed Mogahed

    Tanta, Elgharbia

Other trials in Egypt

About this study

Official title: Macintosh Laryngoscope Versus GlideScope® Versus C-MAC®(D) Videolaryngoscope for Double Lumen Endotracheal Intubation in Patients Undergoing Thoracic Surgery

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.

Conditions
Thoracic
Being tested
Intubation of the double lumen tube by Macintoch laryngoscope, Intubation of the double lumen tube by Glidescope videolaryngoscope, Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope
Keywords
Macintosh, laryngoscope, GlideScope, C-MAC, videolaryngoscope, double lumen tube

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intubation of the double lumen tube by Macintoch laryngoscopeDevice

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

  • Intubation of the double lumen tube by Glidescope videolaryngoscopeDevice

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

  • Intubation of the double lumen tube by C-MAC®(D) videolaryngoscopeDevice

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

Study groups in NCT05091281
Study groupRoleWhat they receive
Group IActive comparatorAfter induction of anesthesia intubation was done by Macintosh laryngoscope
Receives: Device: Intubation of the double lumen tube by Macintoch laryngoscope
Group IIActive comparatorAfter induction of anesthesia intubation was done by GlideScope®videolaryngoscope
Receives: Device: Intubation of the double lumen tube by Glidescope videolaryngoscope
Group IIIActive comparatorAfter induction of anesthesia intubation was done byC-MAC®(D) videolaryngoscope
Receives: Device: Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Double lumen tube insertion times in seconds

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

    Measured: 2 minutes

  2. first-pass success rates

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

    Measured: 2 minutes

Secondary outcomes (2)
  1. Blood pressure measurement in mm Hg

    During intubation and then every 15 minutes in mm Hg

    Measured: 150 minutes

  2. Heart rate measurement in beat/minute

    During intubation and then every 15 minutes in beat/minute

    Measured: 150 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start5 Nov 2021
  3. Primary completion10 Jan 2022
  4. Study completion10 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model 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. After pre-oxygenation , 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 . . 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.
Masking
Single blind
Who is masked
Participant
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05091281
Sponsor's protocol ID
34776/7/21
Status last verified
Jan 2022
First submitted
1 Oct 2021
Last updated
12 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Intubation of the double lumen tube by Macintoch laryngoscope, Intubation of the double lumen tube by Glidescope videolaryngoscope and Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope in people with Thoracic, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double lumen tube insertion times in seconds (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in