Gynecologic CancerNCT07111039
Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventila
A study testing Airway Pressure Release Ventilation and Conventional Mechanical Ventilation in people with Gynecologic Cancer and Genitourinary Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Genitourinary Cancer
- What is being tested?
- Airway Pressure Release Ventilation and Conventional Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Airway Pressure Release Ventilation, Conventional Mechanical Ventilation
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Pressure Release VentilationOther
APRV
Conventional Mechanical VentilationOther
CMV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Airway Pressure Release Ventilation; Other: Conventional Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startMar 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Thrush, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111039
- Sponsor's protocol ID
- MCC-23490
- Status last verified
- May 2026
- First submitted
- 2 Jul 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07111039
- Acronym / sponsor ID
- MCC-23490
- Conditions
- Gynecologic Cancer, Genitourinary Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APRV compared to CMV | Experimental | Other: Airway Pressure Release Ventilation, Other: Conventional Mechanical VentilationAPRV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway Pressure Release VentilationAPRV | Other | APRV compared to CMV |
| Conventional Mechanical VentilationCMV | Other | APRV compared to CMV |
Primary outcome
Optimal intra-operative ventilatory settings - Inspiratory Pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Thrush, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Pressure Release Ventilation and Conventional Mechanical Ventilation in people with Gynecologic Cancer and Genitourinary Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal intra-operative ventilatory settings - Inspiratory Pressure (time frame: At surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.