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

NCT07111039 | Suspended

• 1 other identifier: MCC-23490
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Genitourinary Cancer

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  At surgery

Study Arms (1)

APRV compared to CMV

EXPERIMENTAL

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.

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

Interventions

Airway Pressure Release Ventilation OTHER

APRV

APRV compared to CMV

Conventional Mechanical Ventilation OTHER

CMV

APRV compared to CMV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Urogenital Neoplasms

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• David Thrush, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)