Mechanical Ventilation Pressure High
Conditions
Brief summary
This is a prospective randomized cross over study of healthy volunteers undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as his or her own control.
Detailed description
This is a randomized cross over study. A convenience sample of staff and resident physicians and physician assistants from the San Antonio Military Medical Center (SAMMC) Department of Emergency Medicine will be used to assess NIPPV mask seal during CPAP administration with and without nasal cannula. Volunteers will be solicited via Grand Rounds and staff meetings at San Antonio Military Medical Center. Subjects will undergo permuted block randomization by random number generator to the order of intervention, mask alone or mask with nasal cannula at 15L/min of oxygen. An emergency medicine trained physician will place equipment and operate the ventilator. After placement of the NIPPV mask and prior to each study intervention period, appropriate adjustments to enhance mask seal will be made as would happen in a therapeutic setting and the volunteer will be allowed up to two minutes to acclimate to continuous noninvasive positive pressure ventilation. Mask leak will be measured by the ventilator unit and will be recorded after 60 seconds of spontaneous restful ventilation.
Interventions
DEVICENasal cannula
Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age * Volunteer for study
Exclusion criteria
* Known cardiac disease * Known pulmonary disease (to include respiratory infections)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine | 2 minutes after mask placement | Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Discomfort (Verbal Numerical Rating Scale) | After study completion (approximately 2 minutes after study start) | Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NIPPV With Nasal Cannula First Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation | 32 |
| NIPPV Without Nasal Cannula First Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | NIPPV With Nasal Cannula First | NIPPV Without Nasal Cannula First | Total |
|---|---|---|---|
| Age, Continuous | 31 years | 32 years | 31 years |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine
Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine
Time frame: 2 minutes after mask placement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NIPPV With Nasal Cannula | Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine | 0 Liters per minute |
| NIPPV Without Nasal Cannula | Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine | 0 Liters per minute |
Secondary
Patient Discomfort (Verbal Numerical Rating Scale)
Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)
Time frame: After study completion (approximately 2 minutes after study start)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NIPPV With Nasal Cannula | Patient Discomfort (Verbal Numerical Rating Scale) | 3 Scores on verbal numerical rating scale |
| NIPPV Without Nasal Cannula | Patient Discomfort (Verbal Numerical Rating Scale) | 1 Scores on verbal numerical rating scale |