A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Bladder Capacity
研究概览
简要总结
A urodynamic study (UDS) is a common procedure done to learn more about the cause of urinary symptoms. For some patients, UDS can be associated with anxiety or discomfort. Nitrous oxide (or laughing-gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if giving low-dose (20-50%) nitrous oxide at the time of UDS affects the measurements taken during the procedure, such as how much volume your bladder can hold, and pressures during urination. If the measurements are the same with and without self-administered nitrous oxide (SANO), it could be suggested that nitrous oxide may be a useful way of reducing patient anxiety and pain during UDS.
详细描述
Randomization is performed according to a 1:1 block model immediately before the start of UDS. Patients are randomized to receive oxygen followed by SANO or SANO followed by oxygen. The procedural team and patient are blinded to the treatment. Muscarinic medications are stopped 24 hours prior to UDS, and patients provide a urine sample to confirm negative cultures. In this study, the Nitrouseal® system is utilized to administer adjustable amounts of N2O (20-50%) using a single-use disposable mask. The system scavenges exhaled N2O and limits the maximum amount of N2O to 50%. After fitting the Nitrouseal mask, the patients are instructed on how to communicate with hand signals throughout the study to titrate the level of gas being administered. Patients receive SANO during catheter placement to determine their preferred N2O level. Following a "washout" period of two minutes, patients undergo two UDS fills following the randomization scheme. Residual urine is removed between runs using the UDS catheter.
UDS are performed according to the 2012 AUA/SUFU Adult Urodynamic Guidelines. All UDS are performed on a Laborie Aquarius XT machine (Laborie Medical, Portsmouth, NH) using 7 Fr dual lumen fluid urethral catheters, 9 Fr dual lumen fluid-filled rectal catheters, and EMG gel patch electrodes. Filling is performed at 50 cc/min with normal saline at room temperature. During the voiding phase, patients are positioned to be sitting or standing according to their comfort.
An intention-to-treat analysis is performed on 19 participants. Maximum cystometric capacity is measured as the primary outcome. Secondary outcomes include patient-reported pain and anxiety measured at baseline and immediately before maximum capacity during each UDS run using the Visual Analog Scale for Pain (VAS-P; range 0-10) and the Visual Analog Scale for Anxiety (VAS-A; range 0-10).
The blinded UDS operator assesses patient responsiveness (ability to communicate) and tolerance on a 3-point Likert scale: worse than expected, as expected, or better than expected. Standard UDS parameters per International Continence Society terminology, including first sensation, first desire, strong desire, MCC, bladder compliance (volume/Pdet Max during filling), detrusor overactivity, detrusor sphincter dyssynergia, inability to void, maximum flow rate, Pdet during maximum flow rate, voided volume, post-voided residual, and voided percentage, are compared for significant differences between the SANO and Oxygen runs.
Post-procedure patient surveys are administered to assess personal experience of catheter placement, desire to have SANO for future UDS, and satisfaction with N2O levels. Finally, electronic medical records are monitored for Clavien-Dindo graded complications for up to 30 days following the UDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participant and operating urodynamic study practitioner will be blinded to whether SANO or oxygen is given during the study fills. UDS measurements will be assessed by a blinded urologist.
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled for urodynamic study
- •Aged 21 to 85 years
- •Suitable for inflation of nitrous oxide/oxygen with willingness to undergo two urodynamic study runs during the procedure
- •Access to an email and computer
排除标准
- •Perioral facial hair impeding good mask seal
- •Learning disabilities and/or inability to cognitively complete survey questions
- •Has any of the following medical conditions:
- •Inner ear, bariatric or eye surgery within the last 2 weeks,
- •Current emphysematous blebs,
- •Severe B-12 deficiency,
- •Bleomycin chemotherapy within the past year,
- •Heart attack within the past year,
- •Stroke within the past year,
- •Class III or higher heart failure
研究组 & 干预措施
Oxygen First Arm
All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
In OXYGEN FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with Oxygen. There is a washout period of 2 minutes between the runs. The second UDS run is performed with the predefined participant-preferred level of SANO.
Oxygen Run:
100% oxygen at 10 Liters/minute
Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%)
干预措施: Self-Administered Nitrous Oxide (Drug)
Oxygen First Arm
All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
In OXYGEN FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with Oxygen. There is a washout period of 2 minutes between the runs. The second UDS run is performed with the predefined participant-preferred level of SANO.
Oxygen Run:
100% oxygen at 10 Liters/minute
Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%)
干预措施: Oxygen (Other)
SANO First Arm
All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
In SANO FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with the predefined participant-preferred level of SANO. There is a washout period of 2 minutes between the runs. The second UDS run is performed with Oxygen.
Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%)
Oxygen Run:
100% oxygen at 10 Liters/minute
干预措施: Self-Administered Nitrous Oxide (Drug)
SANO First Arm
All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.
In SANO FIRST arm, each patient undergoes two consecutive UDS runs. The first UDS run is performed with the predefined participant-preferred level of SANO. There is a washout period of 2 minutes between the runs. The second UDS run is performed with Oxygen.
Self-Administered Nitrous Oxide Run: Nitrous oxide administered at previously determined concentration of nitrous oxide (20-50%)
Oxygen Run:
100% oxygen at 10 Liters/minute
干预措施: Oxygen (Other)
结局指标
主要结局
Bladder Capacity
时间窗: Measured at max bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-minute washout; each run lasts ~15-45 minutes depending on individual bladder fill rate
Maximum liquid volume the bladder can hold, measured in milliliters (mL) during urodynamic study (UDS).
次要结局
- Intra-Urodynamic Study (UDS) Pain(Measured at maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.)
- Intra-Urodynamic Study (UDS) Anxiety(Measured at maximum bladder fill during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.)
- Post Void Residual(Measured immediately after voiding during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.)
- Max Flow Rate(Measured at time of maximum urinary flow during voiding in each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.)
- Detrusor Overactivity(Measured during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.)
- Detrusor Pressure at Maximum Flow(Measured at time of maximum urinary flow during each of two consecutive UDS runs on a single study day. Runs occur back-to-back with a 2-min washout; each lasts ~15-45 min depending on fill rate and individual bladder capacity.)
研究者
Heidi Rayala
Assistant Professor of Surgery
Beth Israel Deaconess Medical Center