Anticipated Difficult Airway
Conditions
Brief summary
We propose the additional technique of lingual traction or tongue pulling in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Induction of general anesthesia causes relaxation and approximation of the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual traction can assist in diminishing these problems by clearing the tongue away from the soft palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in the unanticipated difficult airway patient.
Interventions
OTHERLingual Traction
The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
OTHERSham
Standard of care fiberoptic intubation without any additional experimental maneuvers
DEVICEFiberoptic Intubation
Sponsors
Enrico Camporesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years old * With ASA (American Society of Anesthesiologists) physical status I-III * With anticipated difficult airway * Scheduled for elective surgery requiring orotracheal intubation (populations such as elective hip and knee arthroplasty patients) * Provide written consent
Exclusion criteria
* With (American Society of Anesthesiologists) ASA physical status IV * Pregnant * Require rapid-sequence induction * Require a non-standard tracheal tub * Unable to provide written consent * At risk for pulmonary aspiration of gastric content
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured. | At Intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sore Throat Grade on First Postoperative Day | Postoperative day one | Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fiberoptic Intubation Alone Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic Intubation | 39 |
| Fiberoptic Intubation With Lingual Traction Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
Fiberoptic Intubation | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | Fiberoptic Intubation Alone | Total | Fiberoptic Intubation With Lingual Traction |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 12.5 | 56.2 years STANDARD_DEVIATION 13 | 56.7 years STANDARD_DEVIATION 13.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 39 Participants | 78 Participants | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 39 Participants | 78 Participants | 39 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 39 participants | 78 participants | 39 participants |
| Sex: Female, Male Female | 20 Participants | 41 Participants | 21 Participants |
| Sex: Female, Male Male | 19 Participants | 37 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 39 | 6 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.
Time frame: At Intubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fiberoptic Intubation Alone | Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured. | 29 participants |
| Fiberoptic Intubation With Lingual Traction | Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured. | 36 participants |
Secondary
Sore Throat Grade on First Postoperative Day
Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe
Time frame: Postoperative day one
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fiberoptic Intubation Alone | Sore Throat Grade on First Postoperative Day | 10 participants |
| Fiberoptic Intubation With Lingual Traction | Sore Throat Grade on First Postoperative Day | 14 participants |