NCT07111039 - Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventila | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

12

Conditions

Gynecologic Cancer Genitourinary Cancer

Interventions

Airway Pressure Release VentilationOTHER

APRV

Conventional Mechanical VentilationOTHER

CMV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Optimal intra-operative ventilatory settings - Inspiratory Pressure

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).

Time frame: At surgery

Optimal intra-operative ventilatory settings - Expiratory Pressure

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).

Time frame: At surgery

Optimal intra-operative ventilatory settings - Inspiratory-expiratory time ratio

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).

Time frame: At surgery

Optimal intra-operative ventilatory settings - Inspired oxygen concentration

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).

Time frame: At surgery