Macintosh Laryngoscope Assisted Fiberoptic Intubation

October 4, 2018 updated by: Mansoura University

Macintosh Laryngoscope Assisted Flexible Fiber Optic Endotracheal Intubation Versus Classic Fiber Optic Laryngoscope Alone Endotracheal Intubation for Modified Mallampati III&IV Patients : A Prospective Randomized Controlled Study

During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III&VI Modified Mallampati .

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

Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.

All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.

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.
100

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
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Oncolgy Center, Mansoura University,

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with Modified Mallampati (NT-MMT) airway score III,VI
  • American Society of Anaesthesiologists (ASA) physical class I-III
  • Scheduled for elective cancer surgery under general anesthesia

Exclusion Criteria:

  • Modified Mallampati I,II Airway scored patients.
  • History of upper airway surgery.
  • Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.
  • Patients with a history of significant cardiac and pulmonary diseases,
  • Obesity with BMI >40,
  • Epilepsy, pregnancy, mental disease, neurological psychological disorders.
  • Communication barrier.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: fiberoptic, airway
Classical fiberoptic intubation assisted by side fenestrated airway and head tilt- chin lift- jaw thrust by 2 anesthetist
Device: fiberoptic, airway
classic fiberoptic bronchoscope, fenstrated airway
Experimental: fiberoptic, Machintosh
oral Fiberoptic bronchoscopic intubation assisted by Macintosh Laryngoscope, by 2 anesthetist
Device: fiberoptic, Machintosh
oral fiberoptic brochoscopic, Machintosh laryngoscope

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
intubation time
Time Frame: during intubation
time from introduction of the tip of the fiber optic laryngoscope till insertion of the tube in the laryngeal inlet down in the trachea in seconds.
during intubation

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
lower jaw relaxation
Time Frame: during intubation
(Relaxed= 0, not fully=1, poor= 2)
during intubation
Vocal cord position
Time Frame: during intubation
(Abducted= 0, Intermediate opening= 1, Closed= 2)
during intubation
Neck movements
Time Frame: during intubation and cuff inflation
for endotracheal tube or cuff inflation (no=0, slight= 1, vigorous= 2),
during intubation and cuff inflation
Cough
Time Frame: during intubation and cuff inflation
(absent= 0, present=1)
during intubation and cuff inflation
1st trial success rate
Time Frame: during intubation
in percent
during intubation
the number of trails
Time Frame: during intubation
(1st trial=1, 2nd trial= 2, 3rd trial= 3)
during intubation
mean arterial Blood pressure (MBP)
Time Frame: during intubation till 5 minutes after intubation
basal, every minute during intubation, 1, 3, 5 minutes after intubation
during intubation till 5 minutes after intubation
mean heart rate (HR)
Time Frame: during intubation till 5 minutes after intubation
basal, every minute during intubation, 1, 3, 5 minutes after intubation
during intubation till 5 minutes after intubation
desaturation (SpO2)
Time Frame: during intubation
oxygen saturation <90% .(Yes=1, No= 0)
during intubation

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.
Mansoura 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.
December 15, 2017

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.
July 15, 2018

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.
July 30, 2018

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 5, 2017

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 10, 2017

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 16, 2017

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.
October 5, 2018

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.
October 4, 2018

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.
October 1, 2018

More Information

Terms related to this study

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.
  • R/17.08.102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

after publication

IPD Sharing Time Frame

no limit

IPD Sharing Access Criteria

e mail mohamed.abdel_latif@yahoo.com

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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