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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01749631
First received: December 12, 2012
Last updated: February 2, 2016
Last verified: February 2016

December 12, 2012
February 2, 2016
December 2012
February 2015   (final data collection date for primary outcome measure)
Percentage of Participants With Successful Intubation (Clinical Success) [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: No ]
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.
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

Complete list of historical versions of study NCT01749631 on ClinicalTrials.gov Archive Site
  • Mean Duration of Induction (in Seconds) [ Time Frame: From start of induction up to 15 minutes ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Mallampati Score III and IV [ Time Frame: Screening ] [ Designated as safety issue: No ]
    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.
  • Mean Duration of Intubation Procedure (in Minutes) [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: No ]
    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]).
  • Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: Yes ]
    The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.
  • 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) ] [ Designated as safety issue: Yes ]
    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.
  • Mean Number of Intubation Attempts [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: No ]
  • 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
Not Provided
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Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
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.
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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hospitals with operation theaters
Intubation; Difficult
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
February 2015
February 2015   (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 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
Both
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Egypt
 
NCT01749631
P13-805
No
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Amr Alaa AbbVie Egypt
AbbVie
February 2016

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