Otolaryngological Surgery
Conditions
Brief summary
We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.
Interventions
DEVICECuffed ETT
Sponsors
Kris Jatana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
Exclusion criteria
* Patient who is intubated with an uncuffed endotracheal tube. * Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Intracuff Pressure | during time of surgery | Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cuffed ETT Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
Cuffed ETT | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | Cuffed ETT |
|---|---|
| Age, Categorical <=18 years | 84 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 5.7 years STANDARD_DEVIATION 3.9 |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 84 |
| serious Total, serious adverse events | 0 / 84 |
Outcome results
Primary
Changes in the Intracuff Pressure
Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
Time frame: during time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cuffed ETT | Changes in the Intracuff Pressure | 3 cmH2O | Standard Deviation 7 |