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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 5, 2014
Last verified: June 2014
  Purpose

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


Condition
Patients Suspected to Have Difficult Intubation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitals with operation theaters

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749631

Contacts
Contact: Rasha Eldessouky, MD rasha.eldessouky@abbott.com
Contact: Shimaa Magdy, BS Pharm shimaa.magdy@abbott.com

Locations
Egypt
Site Reference ID/Investigator# 87893 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 87893         
Site Reference ID/Investigator# 87914 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 87914         
Site Reference ID/Investigator# 87895 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 87895         
Site Reference ID/Investigator# 87894 Recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 87894         
Site Reference ID/Investigator# 87897 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 87897         
Site Reference ID/Investigator# 87913 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 87913         
Site Reference ID/Investigator# 87896 Not yet recruiting
Giza, Egypt
Principal Investigator: Site Reference ID/Investigator# 87896         
Site Reference ID/Investigator# 77733 Not yet recruiting
Giza, Egypt, 12311
Principal Investigator: Site Reference ID/Investigator# 77733         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rasha Eldessouky Abbott (Egypt)
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01749631     History of Changes
Other Study ID Numbers: P13-805
Study First Received: December 12, 2012
Last Updated: June 5, 2014
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by AbbVie:
Patients suspected to have difficult intubation

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on August 20, 2014