Intubation
Conditions
Keywords
Laryngeal mask, Difficult intubation
Brief summary
The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.
Detailed description
Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices. Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.
Interventions
DEVICEFastrach Laryngeal Mask
Intubation of difficult airway using Fastrach Laryngeal Mask
DEVICECTrach Laryngeal Mask
CTrach Laryngeal Mask intubation
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with an ASA score of 1-3. 2. Scheduled for elective surgical procedure 3. Age 18 and above 4. Patients with Mallampati airway classification scores III and IV
Exclusion criteria
1. Current pregnancy 2. Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures 3. Patients with obstructive sleep apnea or with a history of difficult ventilation 4. Mouth opening less than 3 cm. 5. Patients with indication for awake fiberoptic intubation or with a history of difficult intubation 6. Patients with cancer of the neck or the upper airway 7. Emergent surgery, patients requiring rapid sequence induction 8. Patients with severe gastroesophageal reflux 9. Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy | from start of intubation to successfully intubated |
| To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy | 60 seconds |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fastrach Fastrach Laryngeal Mask Airway intubation
Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask | 23 |
| CTrach Intubation of difficult airway using CTrach Laryngeal Mask
CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation | 20 |
| Total | 43 |
Baseline characteristics
| Characteristic | Fastrach | CTrach | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 16 | 59 years STANDARD_DEVIATION 15 | 59 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
Primary
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy
Time frame: 60 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fastrach | To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy | 35 seconds |
| CTrach | To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy | 40 seconds |
p-value: 0.4595% CI: [0.38, 1.54]Regression, Cox
Primary
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy
Time frame: from start of intubation to successfully intubated
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fastrach | To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy | 41 seconds |
| CTrach | To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy | 40 seconds |
p-value: 0.7295% CI: [0.55, 2.37]Regression, Cox