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

• ClinicalTrials.gov Identifier: NCT01749631
• Recruitment Status: Completed
• First Posted: December 17, 2012
• Results First Posted: March 1, 2016
• Last Update Posted: March 1, 2016
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description

Brief Summary:

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.

Condition or disease
Intubation; Difficult

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 Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Time Perspective: Prospective
• Official Title: A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
• Study Start Date: December 2012
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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]).
4. 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.
5. 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.
6. Mean Number of Intubation Attempts [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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

Contacts and Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Amr Alaa; AbbVie Egypt

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01749631
• Other Study ID Numbers: P13-805
• First Posted: December 17, 2012
• Results First Posted: March 1, 2016
• Last Update Posted: March 1, 2016
• Last Verified: February 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Patients suspected to have difficult intubation; Intratracheal intubation; Difficult to intubate