Intubation; Difficult
Conditions
Keywords
Patients suspected to have difficult intubation, Intratracheal intubation, Difficult to intubate
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.
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successful Intubation (Clinical Success) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Mallampati Score III and IV | 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) | 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 \[PETCO2\]). |
| Mean Duration of Induction (in Seconds) | 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 Who Experienced Difficulties Related to the Use of Sevoflurane | 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 | Start of intubation to completion of intubation (up to 15 minutes) | — |
| Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure | 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. |
Participant flow
Pre-assignment details
A total of 97 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant did not meet the criteria Mallampati Score III or IV and was excluded from the per protocol population, which consisted of 96 participants.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | Difficult to Intubate (DTI) Participants |
|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 15.04 |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 97 |
| serious Total, serious adverse events | 0 / 97 |
Outcome results
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.
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Percentage of Participants With Successful Intubation (Clinical Success) | Success | 96.9 percentage of participants |
| Difficult to Intubate (DTI) Participants | Percentage of Participants With Successful Intubation (Clinical Success) | Failure | 3.1 percentage of participants |
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.
Time frame: From start of induction up to 15 minutes
Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Mean Duration of Induction (in Seconds) | 220.45 seconds | Standard Error 23.43 |
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 \[PETCO2\]).
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Mean Duration of Intubation Procedure (in Minutes) | 1.77 minutes | Standard Error 0.2 |
Secondary
Mean Number of Intubation Attempts
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Mean Number of Intubation Attempts | 1.26 number of attempts | Standard Error 0.5 |
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.
Time frame: Start of intubation to completion of intubation (up to 15 minutes)
Population: ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure | Hypertension | 1.03 percentage of participants |
| Difficult to Intubate (DTI) Participants | Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure | Cough | 1.03 percentage of participants |
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.
Time frame: From start of induction to completion of intubation (up to 30 minutes)
Population: ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Difficult to Intubate (DTI) Participants | Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane | 0 percentage of participants |
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.
Time frame: Screening
Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Percentage of Participants With Mallampati Score III and IV | Class III | 93.8 percentage of participants |
| Difficult to Intubate (DTI) Participants | Percentage of Participants With Mallampati Score III and IV | Class IV | 5.2 percentage of participants |