The Efficiency of Different Oropharyngeal Airways as a Conduit for Fiberoptic Intubation. Comparative Study

May 31, 2017 updated by: Sara Ahmed Abdallah, Kasr El Aini Hospital
60 Patients were randomly allocated into three equal groups, after induction of general anesthesia one of the three airways included in the study (Modified Williams, Modified Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using fiberoptic bronchoscopy. Airway insertion time, ease of insertion, adaptation to oral cavity and intubation time was recorded.

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

The study was conducted in Kasr Alainy hospital, faculty of medicine, Cairo University.

After approval of ethical committee and informed written consent from each patient, 60 patient aging above 18 years, ASA I-II , with Ganzouri airway score <4 and undergoing elective surgeries under general anesthesia were included in the study.

Patients were randomly allocated into three equal groups:

Group M (GM) (n=20 patients): patient was intubated using LMA MADgic airway. Group W (GW) (n=20 patients): patient was intubated using modified Williams airway.

Group G (GG) (n=20 patients): patient was intubated using modified Guedel's airway.

Randomization was performed by random computer allocation with numbered closed opaque envelopes.

The study was performed by expert anesthesiologist in FOB intubation. In the preparation room, all patients was cannulated with a 20 gauge venous cannula and 0.02mg/kg Midazolam was given. Patient transferred to the operating room and was monitored with non-invasive blood pressure, pulse oximetry and ECG. After preoxygenation using a facemask for 5 min, induction of anesthesia was done with 2mg/kg propofol, 1 μg/kg of fentanyl and 0.6 mg/kg of atracurium.

After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion according to manufacturer instruction). Time of insertion defined as the time, in seconds, from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask. The ease of insertion was determined by number of attempts of airway insertion. Adaptation of the airway was determined by adequacy of ventilation, fitness to the oral cavity and appearance of successive ETco2 waves.

Manual positive-pressure ventilation was then started with 100% oxygen and 1-1.5% isoflurane through the facemask for 3 min until complete muscle relaxation was confirmed (when train-of-four count becomes zero).

Loaded FOB was inserted for intubation through the airway, laryngeal view grade was recorded (LVG) using Brimacomb and Berry scale; thereafter, the fiberscope was advanced into the trachea to a level just above the carina and the tracheal tube was railroaded over it.

Tracheal intubation could be facilitated by tube rotation, jaw thrust, neck extension or flexion and adjustment of the airway was allawed and was recorded. The intubation time was recorded ; that is, the time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube.

The airway was removed except the LMA MADgic airway which was removed before ETT insertion. The ease of airway removal was evaluated by the anesthesiologist.

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.
60

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

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical state I-II Ganzouri airway score less than 4

Exclusion Criteria:

  • ASA physical state III-IV. Patients with Ganzouri airway score more than 4. Patients with risk of aspiration of gastric content. Any anatomical abnormalities or iatrogenic injuries that invalidate Ganzouri airway score.

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
Experimental: Group W
This group was intubated by Fiberoptic bronchoscope assisted by Modified Williams airway as a conduit
Device: Modified Williams airway
This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group W
Other Names:
  • Fikrey airway
Experimental: Group G
This group was intubated by Fiberoptic bronchoscope assisted by Modified Guedle's airway as a conduit
Device: Modified Guedle's airway
This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group G
Experimental: Group M
This group was intubated by Fiberoptic bronchoscope assisted by LMA MADgic airway as a conduit
Device: LMA MADgic airway
This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group M

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
Time of intubation
Time Frame: within 15 minutes from induction of general anesthesia
The time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube
within 15 minutes from induction of general anesthesia

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
Time of insertion
Time Frame: within 15 minutes from induction of general anesthesia
Time from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask
within 15 minutes from induction of general anesthesia
Laryngeal View Grade
Time Frame: within 15 minutes from induction of general anesthesia
Degree of vocal cord visualization by fiberoptic bronchoscope
within 15 minutes from induction of general anesthesia

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.
Kasr El Aini Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Ahmed Abdallah, Master, Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Dina N. Abbas, Ekramey M. Abdghaffar. Comparison of the air-Q intubating laryngeal airway versus the modified Williams intubating airway as aids for training in fiberoptic tracheal intubation. Ain-Shams Journal of Anesthesiology 2013, 6:134-139.

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.
June 1, 2016

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.
April 1, 2017

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.
May 1, 2017

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).
May 27, 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.
May 31, 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.
June 2, 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.
June 2, 2017

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.
May 31, 2017

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.
May 1, 2017

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.
  • N-40-2016

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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