Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventila

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer; Genitourinary Cancer

• Registration Number: NCT07111039
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-02
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States