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

Intubation; Difficult Clinical Trial

Official title:

A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749631
• Other study ID #: P13-805
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: February 2, 2016
• Start date: December 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Intubation; Difficult

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Successful Intubation (Clinical Success)	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.	Start of intubation to completion of intubation (up to 15 minutes)	No
Secondary	Mean Duration of Induction (in Seconds)	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.	From start of induction up to 15 minutes	No
Secondary	Percentage of Participants With Mallampati Score III and IV	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.	Screening	No
Secondary	Mean Duration of Intubation Procedure (in 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]).	Start of intubation to completion of intubation (up to 15 minutes)	No
Secondary	Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure	The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.	Start of intubation to completion of intubation (up to 15 minutes)	Yes
Secondary	Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane	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.	From start of induction to completion of intubation (up to 30 minutes)	Yes
Secondary	Mean Number of Intubation Attempts		Start of intubation to completion of intubation (up to 15 minutes)	No

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