Surgical Procedure, Unspecified
Conditions
Brief summary
To date, there are no data in the literature regarding changes in the intracuff pressure during prolonged surgical procedures. It is possible that the pressure will increase over time related to gas expansion during equilibration to body temperature. If this is the case, these patients may be at risk for tracheal damage. This is a prospective study to evaluate the changes in intracuff pressure over time during prolonged surgical procedures.
Interventions
OTHERCuff pressure
Measuring endotracheal tube (ETT) cuff pressure
Sponsors
Senthil G. Krishna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients in whom a cuffed endotracheal tube is to be used for surgical procedures of more than 4 hours.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Intracuff Pressure | 1 day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Patients Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure | 33 |
| Non-cardiac Patients Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure | 30 |
| Total | 63 |
Baseline characteristics
| Characteristic | Non-cardiac Patients | Cardiac Patients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 33 Participants | 63 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.9 years STANDARD_DEVIATION 5.1 | 2.8 years STANDARD_DEVIATION 3.6 | 8.2 years STANDARD_DEVIATION 6.7 |
| Region of Enrollment United States | 30 participants | 33 participants | 63 participants |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 32 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 30 |
| serious Total, serious adverse events | 0 / 33 | 0 / 30 |
Outcome results
Primary
Change in Intracuff Pressure
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiac Patients | Change in Intracuff Pressure | -11.8 cmH2O | Standard Deviation 6.4 |
| Non-cardiac Patients | Change in Intracuff Pressure | -9.5 cmH2O | Standard Deviation 29.7 |