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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||97 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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]).
- 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.
- 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.
- Mean Number of Intubation Attempts [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749631
|Study Director:||Amr Alaa||AbbVie Egypt|