Dysphagia, Hoarseness, Post Operative Sore Throat
Conditions
Keywords
sore throat, dysphagia, hoarseness, post operative, endotracheal intubation
Brief summary
The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique. The investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.
Interventions
DEVICEcuff manometer
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours * ASA I-3
Exclusion criteria
* Planned prolonged intubation * Planned postoperative ICU admission * Non English speaking * Mentally impaired * Existing tracheal stoma * Nasogastric tube in place preoperative * Thyroid / intra-oral surgery * Previous general anesthesia within the last 2 weeks * Use of steroids within one week before surgery (IV,inhaled, oral)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Tracheopharyngeal Symptoms | within 2 hours after extubation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Endotracheal tube cuff inflated using the inflate & palpate technique | 69 |
| Intervention Group Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff. | 64 |
| Total | 133 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 15.8 | 50.3 years STANDARD_DEVIATION 13.8 | 51.4 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment United States | 69 participants | 64 participants | 133 participants |
| Sex: Female, Male Female | 32 Participants | 34 Participants | 66 Participants |
| Sex: Female, Male Male | 37 Participants | 30 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 64 |
| serious Total, serious adverse events | 0 / 69 | 0 / 64 |
Outcome results
Primary
Incidence of Tracheopharyngeal Symptoms
Time frame: within 2 hours after extubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Incidence of Tracheopharyngeal Symptoms | 53 participants |
| Intervention Group | Incidence of Tracheopharyngeal Symptoms | 49 participants |