Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

February 2, 2016 updated by: AbbVie (prior sponsor, Abbott)

A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success.

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.

Detailed Description

This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of sevoflurane anaesthesia in difficult to intubate (DTI; Mallampati Score III or IV) Egyptian patients who had been prescribed sevoflurane for anaesthesia by their treating physician.

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.
Observational

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.
97

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitals with operation theaters

Description

Inclusion Criteria:

1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV

2. Patients with at least one of the below criteria:

  1. Anatomic

    • micrognathia - small mandible
    • macroglossia - large tongue
    • short or fixed neck
    • anterior vocal cords
  2. Trauma - neck or face
  3. Burns - airway edema

  4. Infections - edema

    • Retropharyngeal abscess
    • Submandibular abscess
    • epiglottitis
    • laryngotracheobronchitis (croup)
  5. Neoplasms; e.g., laryngeal tumors
  6. Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
  7. Diabetes mellitus
  8. Waxy skin - palm test
  9. Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
  10. airway closure in supine position
  11. Morbid obesity (body mass index [BMI] >35)
  12. Airway edema
  13. Laryngospasm
  14. Edentulous patients - indent cheeks.

3. Patients willing to sign informed consent

Exclusion Criteria:

  1. Patients with present use of opioids and/or narcotic dependent.
  2. Patients with known sensitivity to sevoflurane or to other halogenated agents.
  3. Patients with known or suspected genetic susceptibility to malignant hyperthermia.
  4. Alcohol addictive patients.
  5. Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
  6. Patient is a pregnant or breastfeeding female

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Difficult to Intubate (DTI) Participants
Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

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
Percentage of Participants With Successful Intubation (Clinical Success)
Time Frame: Start of intubation to completion of intubation (up to 15 minutes)
Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.
Start of intubation to completion of intubation (up to 15 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
Mean Duration of Induction (in Seconds)
Time Frame: From start of induction up to 15 minutes
The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.
From start of induction up to 15 minutes
Percentage of Participants With Mallampati Score III and IV
Time Frame: Screening
Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.
Screening
Mean Duration of Intubation Procedure (in Minutes)
Time Frame: Start of intubation to completion of intubation (up to 15 minutes)
The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).
Start of intubation to completion of intubation (up to 15 minutes)
Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure
Time Frame: Start of intubation to completion of intubation (up to 15 minutes)
The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.
Start of intubation to completion of intubation (up to 15 minutes)
Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane
Time Frame: From start of induction to completion of intubation (up to 30 minutes)
The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.
From start of induction to completion of intubation (up to 30 minutes)
Mean Number of Intubation Attempts
Time Frame: Start of intubation to completion of intubation (up to 15 minutes)
Start of intubation to completion of intubation (up to 15 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.
AbbVie (prior sponsor, Abbott)

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.
  • Study Director: Amr Alaa, AbbVie Egypt

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.

Helpful Links

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

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 1, 2012

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.
February 1, 2015

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.
February 1, 2015

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).
December 12, 2012

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.
December 12, 2012

First Posted (Estimate)

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.
December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
March 1, 2016

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.
February 2, 2016

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.
February 1, 2016

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.
  • P13-805

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings