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NCT07111039 | RECRUITING | Gynecologic Cancer

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

Condition or disease

Gynecologic Cancer

Genitourinary Cancer

Intervention/treatment

Airway Pressure Release Ventilation

Conventional Mechanical Ventilation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Pilot Study to Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventilation (CMV) During Anesthesia for Robotic-Assisted Gynecological and Genitourinary Operative Procedures
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventila

Location Details

NCT07111039

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Locations

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612