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

NCT ID: NCT07111039

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-07-31

Brief Summary

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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

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Conditions

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Gynecologic Cancer Genitourinary Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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APRV compared to 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.

Group Type EXPERIMENTAL

Airway Pressure Release Ventilation

Intervention Type OTHER

APRV

Conventional Mechanical Ventilation

Intervention Type OTHER

CMV

Interventions

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Airway Pressure Release Ventilation

APRV

Intervention Type OTHER

Conventional Mechanical Ventilation

CMV

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Thrush, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-23490

Identifier Type: -

Identifier Source: org_study_id

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