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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01749631
First received: December 12, 2012
Last updated: September 19, 2014
Last verified: August 2014

December 12, 2012
September 19, 2014
October 2012
October 2014   (final data collection date for primary outcome measure)
The rate of intubation success (the percentage of patients for whom intubation was successful) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

- The primary endpoint is the rate of intubation success (the percentage of patients for whom intubation was successful). A success is defined as intubation achieved in less than four attempts.

Patient is either considered a success or failure. Number of Intubation Attempts (following the guidelines of ASA) is a maximum of three attempts after which patient will be considered a failure

Same as current
Complete list of historical versions of study NCT01749631 on ClinicalTrials.gov Archive Site
  • The mean duration of induction (in seconds) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The mean duration of induction (in seconds) defined as the time required to reach a Ramsay score of 5 from start of induction
  • The mean duration of intubation procedure (in minutes) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The mean duration of intubation procedure (in minutes) defined as the time from intubation start to the completion of the intubation process(from tube introduction to PETCO2)
  • Percentage of patients who experienced complications resulting from intubation procedure [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Percentage of patients who experienced complications resulting from intubation procedure (including but not limited to: bleeding, salivating, lung aspiration)
  • Percentage of patients who experienced difficulties related to the use of sevoflurane [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Percentage of patients who experienced difficulties related to the use of sevoflurane (including but not limited to: vocal cords adduction, coughing, movements, apnea episodes)
  • The mean number of intubation attempts [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The mean number of intubation attempts
Same as current
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Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
A Prospective, 1 Year, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Value of Sevoflurane Anaesthesia of Difficult to Intubation Patients in Egyptian Population

This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of Sevoflurane anaesthesia in difficult to intubate Egyptian patients.

This study aims to evaluate the effectiveness of sevoflurane in intubation in Egyptian, non obstetric patients undergoing surgery who suffer from suspected difficult intubation.

The study will collect clinical data from approximately 97 difficult to intubation patients who has been administered sevoflurane during anesthesia induction in the operating room. The intubation success rate and duration of intubation will be calculated.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Hospitals with operation theaters

Patients Suspected to Have Difficult Intubation
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DTI patients
Male or non pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent with Mallampati score III or IV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent 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 - TMJ immobility
  7. Diabetes mellitus
  8. Waxy skin - palm test
  9. Decreased 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 (BMI >35)
  12. Airway edema
  13. Laryngospasm
  14. Edentulous patients - no 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
Both
18 Years and older
No
Contact: Rasha Eldessouky, MD rasha.eldessouky@abbott.com
Contact: Shimaa Magdy, BS Pharm shimaa.magdy@abbott.com
Egypt
 
NCT01749631
P13-805
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Rasha Eldessouky Abbott (Egypt)
AbbVie
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP