Clinical trial · Interventional
Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventila
Pilot Study to Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventilation (CMV) During Anesthesia for Robotic-Assisted Gynecological and Genitourinary Operative Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genitourinary Cancer | Malignant Genitourinary System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Airway Pressure Release Ventilation | Other | — | UNRESOLVED |
| Conventional Mechanical Ventilation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- APRV compared to CMV
- description
- 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.
- interventionNames
- Other: Airway Pressure Release Ventilation
- Other: Conventional Mechanical Ventilation
Primary outcomes (4)
- measure
- Optimal intra-operative ventilatory settings - Inspiratory Pressure
- timeFrame
- At surgery
- description
- 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).
- measure
- Optimal intra-operative ventilatory settings - Expiratory Pressure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available