Airway Pressure Release Ventilation for Cancer

Overseen By David Thrush, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: COPD, Major lung resection, BMI >50, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: At surgery

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Airway Pressure Release Ventilation (APRV), a special method of assisting patients' breathing during surgery, can improve lung function compared to the usual method. It focuses on patients with confirmed gynecological or genitourinary cancers undergoing robotic-assisted surgery. Eligible participants have cancer in the pelvic area and are scheduled for surgery with anesthesia.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance surgical outcomes.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Airway Pressure Release Ventilation is safe for use during anesthesia?

Studies have shown that Airway Pressure Release Ventilation (APRV) is generally safe for patients and can sometimes lower the risk of death in the hospital. It may also reduce the time patients need breathing support and their stay in the intensive care unit (ICU). Additionally, APRV can improve lung function by facilitating easier air movement.

Research has found that APRV can increase oxygen levels in patients with serious lung problems, such as acute respiratory distress syndrome (ARDS). This indicates that the lungs are receiving more oxygen, which is crucial for recovery.

Overall, these studies suggest that patients usually tolerate APRV well. No major issues or risks have been reported with using APRV in these situations. However, discussing any concerns with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Airway Pressure Release Ventilation (APRV) because it offers a unique approach to supporting patients during surgery for cancer treatment. Unlike conventional mechanical ventilation (CMV), which maintains constant pressure, APRV cycles between high and low pressures, potentially improving oxygenation and reducing lung injury. This could be particularly beneficial for patients undergoing complex surgeries, as it might enhance recovery and reduce complications.

What evidence suggests that Airway Pressure Release Ventilation is effective for improving pulmonary function during cancer surgery?

This trial will compare Airway Pressure Release Ventilation (APRV) with Conventional Mechanical Ventilation (CMV) during anesthesia in patients undergoing robotic-assisted gynecological or genitourinary surgical procedures for definitive cancer treatment. Studies have shown that APRV can improve lung function by enhancing breathing and oxygen levels. Specifically, one study found that APRV improved blood oxygen levels in patients with Acute Respiratory Distress Syndrome (ARDS). Research indicates that APRV can reduce the risk of developing ARDS and lower hospital mortality rates. Additionally, APRV increases average air pressure in the lungs, which can enhance lung function during surgeries. These findings suggest that APRV might effectively enhance lung performance during operations. ^{1 6 7 8 9}

Who Is on the Research Team?

David Thrush, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients undergoing robotic-assisted surgeries for gynecological or genitourinary cancers. Participants must be suitable candidates for general anesthesia and the specific surgical procedures involved.

Inclusion Criteria

My cancer is confirmed to be in the reproductive organs.

I am physically fit for a robotic surgery with anesthesia.

I am 18 years old or older.

Exclusion Criteria

Patients with body mass index (BMI) >50 are excluded

I do not have COPD requiring daily inhalers or daytime oxygen.

Patients known to be pregnant per operating room (OR) policy will be excluded due to the unestablished availability of oxygen to a fetus during the experimental procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

APRV and CMV are tested during anesthesia in patients undergoing robotic-assisted surgical procedures

At surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airway Pressure Release Ventilation
• Conventional Mechanical Ventilation

Trial Overview The study compares two types of ventilation during surgery: Airway Pressure Release Ventilation (APRV) and standard Conventional Mechanical Ventilation (CMV). It aims to see if APRV improves lung function in 12 patients receiving cancer treatment.

How Is the Trial Designed?

Group I: APRV compared to CMV Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11316212/

A Comparison of Short-Term Outcomes of Robotic-Assisted ... This study compared the short-term perioperative outcomes of lung resection surgeries performed using RATS and video-assisted thoracic surgery (VATS) at a ...

2. accjournal.org accjournal.org/journal/view.php?number=1084

Experiences Using Airway Pressure Release Ventilation ... The use of APRV, however, resulted in improved ventilation and oxygenation and increased mean alveolar pressure. Additionally, many studies have ...

3. apm.amegroups.org apm.amegroups.org/article/view/76407/html

Efficacy of airway pressure release ventilation for acute ... (25), Early application of APRV in traumatic patients represented lower mean ARDS incidence (14.0% vs. 1.3%) and in-hospital mortality (14.1% vs. 3.9%) compared ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/01030/the_safety_and_efficacy_of_airway_pressure_release.44.aspx

The safety and efficacy of airway pressure release... Our study demonstrated that the APRV could increase the PaO 2/FiO 2 ratio significantly in ARDS patients. However, no evidence was demonstrated that APRV could ...

5. researchgate.net researchgate.net/publication/20017662_Airway_pressure_release_ventilation_APRV_A_human_trial

Airway pressure release ventilation (APRV). A human trial During APRV, airway pressure (Paw) was reduced periodically at the lowest frequency which produced normal PaCO2. As anesthesia resolved, the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677621/

Lung mechanics during video-assisted abdominal surgery ... The primary outcome was to assess the effects of pneumoperitoneum on lung compliance and airway pressure during video-assisted surgery (VAS) in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818015001713

Respiratory gas exchange during robotic-assisted ... Laparoscopic prostatectomy adversely affects total respiratory compliance. · As a result, the alveolar partial pressure of oxygen to Pao2 gradient increases.

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/1903023

Mechanical Breath Profile of Airway Pressure Release ... In this study, rats were randomized to controlled mandatory ventilation or airway pressure release ventilation to determine whether airway pressure.

9. atm.amegroups.org atm.amegroups.org/article/view/59063/html

Airway pressure release ventilation versus low tidal volume ... The meta-analysis showed that the APRV reduced death during hospitalization, duration of ventilation, and ICU stay, and improved lung compliance ...