Gynecologic Cancer, Genitourinary Cancer
Conditions
Brief summary
This is a pilot study to determine if pulmonary function (lung compliance and ventilation/perfusion matching) is improved using APRV during general anesthesia, compared to the standard CMV. APRV will be tested during anesthesia in 12 patients undergoing robotic-assisted gynecological or genitourinary surgical procedures for definitive cancer treatment, who will also receive CMV.
Interventions
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have histologically or cytologically confirmed gynecological or genitourinary cancer. * Subjects will have the physiologic reserve to undergo a robotic-assisted gynecological or genitourinary surgical procedure that uses anesthesia via Airway Pressure Release Ventilation and via Conventional Mechanical Ventilation. * Adults (≥18 years old) * ECOG performance status ≤ 2. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Vulnerable subjects will not be enrolled for this study. * Patients who have COPD and are on oxygen at home or who have COPD requiring routine daily inhalers or daytime oxygen are excluded. * Patients who have history of major lung resection are excluded. * Patients with body mass index (BMI) \>50 are excluded. * Patients with pulmonary infection within the past 2 months of screening are excluded. * The availability of oxygen to a fetus during this experimental procedure has not been established. Therefore, patients known to be pregnant per operating room (OR) policy will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal intra-operative ventilatory settings - Inspiratory Pressure | At surgery | Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange). |
| Optimal intra-operative ventilatory settings - Expiratory Pressure | At surgery | Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange). |
| Optimal intra-operative ventilatory settings - Inspiratory-expiratory time ratio | At surgery | Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange). |
| Optimal intra-operative ventilatory settings - Inspired oxygen concentration | At surgery | Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Thrush, MD
Moffitt Cancer Center
Outcome results
None listed