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

H. Lee Moffitt Cancer Center and Research Institute

Status: Suspended

Conditions: Genitourinary Cancer; Gynecologic Cancer

Treatments: Other: Airway Pressure Release Ventilation; Other: Conventional Mechanical Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07111039

MCC-23490

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

APRV compared to CMV

Experimental group

Description:

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.

Treatment:

Other: Conventional Mechanical Ventilation

Other: Airway Pressure Release Ventilation