Anesthesia, Thoracic
Conditions
Keywords
thoracic epidural, pressure measurement, device
Brief summary
The purpose of this pilot study is to evaluate whether the Compuflo Epidural Instrument injection pump technology, which is FDA approved for lumbar epidural anesthesia, is also capable of identifying the thoracic epidural space through measurement of pressure levels. While this device is approved by the FDA for use in the procedure of the lumbar epidural, it is not used to perform the epidural procedure but rather to measure the epidural pressure. This study will likewise measure the epidural pressure.
Interventions
DEVICECompuflo Epidural Instrument
Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 years inclusive * BMI 18.5 to 40 inclusive * Scheduled for thoracic epidural anesthesia
Exclusion criteria
* Patients younger than 18 years or older than 80 years of age * Patients with BMI less than 18.5 or greater than 40 * Contraindication to thoracic epidural anesthesia * Allergy or hypersensitivity to local anesthetics * Patients with preexisting nerve damage * Patients unable to provide written informed consent * Individuals of vulnerable populations: children, pregnant women, prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Levels in Thoracic Epidural Space | Day 1 | The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique | Day 1 | Percent of thoracic epidural anesthesia procedures using LOR that result in a loss of sensation to cold in at least one dermatome, either unilateral or bilateral |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase A - Thoracic ES With LOR Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.
Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia. | 2 |
| Phase B - Thoracic ES With Compuflo Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.
Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia. | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Phase A - Thoracic ES With LOR | Phase B - Thoracic ES With Compuflo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 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 | 2 Participants | 0 Participants | 2 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pressure Levels in Thoracic Epidural Space
The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space
Time frame: Day 1
Population: No participants were enrolled in phase B prior to study termination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase A - Thoracic ES With LOR | Pressure Levels in Thoracic Epidural Space | NA mmHg |
Secondary
Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique
Percent of thoracic epidural anesthesia procedures using LOR that result in a loss of sensation to cold in at least one dermatome, either unilateral or bilateral
Time frame: Day 1
Population: No participants were enrolled in phase B prior to study termination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase A - Thoracic ES With LOR | Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique | NA Percent of successful performance |