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

January 11, 2022 updated by: Mona Mohamed Mogahed, Tanta University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elgharbia
      • Tanta, Elgharbia, Egypt
        • Mona Mohamed Mogahed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group I
After induction of anesthesia intubation was done by Macintosh laryngoscope
Device: Intubation of the double lumen tube by Macintoch laryngoscope
After induction of anesthesia insertion of the double lumen tube was done by Macintosh 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
After induction of anesthesia insertion of the double lumen tube was done 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
After induction of anesthesia insertion of the double lumen tube was done by C-MAC®(D) videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Double lumen tube insertion times in seconds
Time Frame: 2 minutes
Double lumen tube insertion times by the three types of laryngoscopes were recorded
2 minutes
first-pass success rates
Time Frame: 2 minutes
Double lumen tube insertion first-pass success ratesby the three types of laryngoscopes were recorded
2 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure measurement in mm Hg
Time Frame: 150 minutes
During intubation and then every 15 minutes in mm Hg
150 minutes
Heart rate measurement in beat/minute
Time Frame: 150 minutes
During intubation and then every 15 minutes in beat/minute
150 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 34776/7/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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