Pulmonary Ventilation
Conditions
Keywords
Tegaderm bandage, Bag mask ventilation
Brief summary
Difficult Bag Mask Ventilation is well described in the anesthesiology literature, and bearded patients are likely to experience this phenomenon. This study involves application of a large and perforated Tegaderm® across the lower face of the bearded patient to quantify its effectiveness at improving mask ventilation in this anesthetized population.
Detailed description
This study is a prospective crossover trial in bearded patients who will undergo elective or urgent surgery at the main operating rooms of the University of New Mexico Hospital. It is planned to test the efficacy of the novel bag mask ventilation augmentation technique of placing a large perforated Tegaderm® over the mouth of bearded male patients in order to improve seal after induction of general anesthesia. The perforation is a diamond-shaped hole to be aligned with the patient's mouth. Patients will either start with Tegaderm application or without Tegaderm, and will then cross over to the other condition in order to be their own controls. The primary endpoint is to measure inspiratory and expiratory tidal volumes. If shown efficacious this intervention would be an easy and cost-effective intervention to improve bag mask ventilation for bearded patients in the operating room and non-operating room environments alike.
Interventions
DEVICETegaderm placement
Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation
OTHERNo Tegaderm
Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with perioral facial hair \>5mm in length * Undergoing elective non-cardiac surgery with planned bag-mask ventilation during anesthesia induction
Exclusion criteria
* Known allergy to Tegaderm product and/or its adhesive * Emergency surgery * Active or unstable cardiac disease * ASA (American Society of Anesthesiologists) physical status ≥4 * External or internal active airway obstruction from tumor, abscess, or laryngeal edema * Organic or non-organic oropharyngeal anatomical defects including history of radiation treatment to the neck * Moderate to severe acute and chronic restrictive or obstructive lung diseases, e.g. chronic obstructive pulmonary disease, asthma, etc. * Requirement for rapid sequence intubation, or known aspiration risk * Cervical spine injury * Previously documented difficult mask ventilation or intubation * BMI ≥50 * Vulnerable populations: children, prisoners, pregnant patients, cognitively impaired adults
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Air Leakage During Bag-mask Ventilation | <5 minutes | Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resistance | <5 minutes | Airflow resistance during bag-mask ventilation |
| Peak Inspiratory Pressure | <5 minutes | Maximum air pressure observed during bag-mask ventilation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants in the study | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 15 | — |
| Beard Length >1 cm | 8 Participants | — |
| Beard Length 1 cm | 6 Participants | — |
| Beard Length 5-9 mm | 3 Participants | — |
| Beard Length 5 mm | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Percent Air Leakage During Bag-mask Ventilation
Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.
Time frame: <5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bag-mask Ventilation With Tegaderm Placement | Percent Air Leakage During Bag-mask Ventilation | 47.6 percentage of inspired tidal volume | Standard Deviation 26.2 |
| Bag-mask Ventilation Without Tegaderm Placement | Percent Air Leakage During Bag-mask Ventilation | 45.7 percentage of inspired tidal volume | Standard Deviation 20.4 |
Comparison: Null hypothesis: No difference in percent air leakagep-value: 0.66795% CI: [-7, 10.7]Paired t-test
Secondary
Peak Inspiratory Pressure
Maximum air pressure observed during bag-mask ventilation
Time frame: <5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bag-mask Ventilation With Tegaderm Placement | Peak Inspiratory Pressure | 19.3 cm H2O | Standard Deviation 1.6 |
| Bag-mask Ventilation Without Tegaderm Placement | Peak Inspiratory Pressure | 19.4 cm H2O | Standard Deviation 1.3 |
p-value: 0.45595% CI: [-0.5, 0.2]Paired t-test
Secondary
Resistance
Airflow resistance during bag-mask ventilation
Time frame: <5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bag-mask Ventilation With Tegaderm Placement | Resistance | 8.83 cm H2O/L/s | Standard Deviation 5.57 |
| Bag-mask Ventilation Without Tegaderm Placement | Resistance | 7.73 cm H2O/L/s | Standard Deviation 3.69 |
p-value: 0.21895% CI: [-0.7, 2.9]Paired t-test