Comparison Between Low Pressure (8 mmHg) AirSeal Insufflation vs Standard Pressure (15 mmHg) Pneumoperitoneum on Postoperative Recovery in Minimally Invasive Robotic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order
研究概览
简要总结
During surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery.
The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during robotic surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.
The study includes adults aged 18 or older having robotic at New York-Presbyterian Hospital/Weill Cornell Medical Center.
The main questions this clinical trial aims to answer are:
- Does using lower gas pressure shorten the time people spend in the recovery room after surgery?
- Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?
详细描述
Robotic surgeries require the use of pneumoperitoneum, which is a standard of care as it creates a working environment to utilize minimally invasive tools to accomplish surgical procedures. However, there is no uniform standard pressure (usually between 12-15 mmHg). Moreover, maintaining the same pressure throughout the procedure can be inconsistent at best. Elevations in pneumoperitoneum cause significant stretch to the peritoneum which results in significant postoperative pain, longer post-anesthesia care unit (PACU) stay times, and higher opioid consumption. These effects are amplified to a higher degree in patients with severe obesity. If the pressures can be maintained and set to lower levels, then patients may have the opportunity to recover in the immediate postoperative period.
The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery.
This study is a prospective, single-center, single-blind, double-arm parallel-group randomized controlled trial that aims to determine if the use of low-pressure (8 mmHg) AirSeal insufflation, compared to standard-pressure (15 mmHg) pneumoperitoneum, provides superior patient outcomes in terms of post-operative recovery time and convalescence.
During the preoperative evaluation, participants will be consented and enrolled into the trial. Participants will then be randomly allocated to either low-pressure AirSeal insufflation (8 mmHg) or standard-pressure pneumoperitoneum (15 mmHg). Patients and outcome assessors will be blinded to allocation; however, for safety purposes, the operating surgeon and anesthesiologist cannot be blinded.
Intraoperative data (including operation time, estimated blood loss, abdominal pressure, and pressure deviations) will be recorded. Participant data related to comorbidities (i.e. body mass index, American Society of Anesthesiologists physical status, hypertension, diabetes, obstructive sleep apnea, chronic obstructive pulmonary disease/asthma, and smoking status) will be collected from the electronic medical record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Scheduled to undergo robotic-assisted surgery at New York-Presbyterian/Weill Cornell Medical Center
- •American Society of Anesthesiologists physical status I-III
- •Able to understand and provide written informed consent in English
排除标准
- •American Society of Anesthesiologists physical status IV or higher (i.e. a severe systemic disease that is a constant threat to life such as decompensated heart failure)
- •Chronic opioid use (≥30 morphine milligram equivalents per day for ≥30 days within the past 6 months)
- •Current pregnancy
- •Inability to understand and provide informed consent in English
- •Inability to provide informed consent due to cognitive impairment or other conditions impacting decision-making capacity
- •Scheduled open or laparoscopic surgeries
研究组 & 干预措施
Low-pressure pneumoperitoneum (AirSeal)
Participants who are assigned to this arm will receive 8 mmHg pneumoperitoneum using the AirSeal Robotic Solution device.
The AirSeal Robotic Solution device is a FDA 510(k)-cleared carbon dioxide insufflation platform with valveless trocar technology that helps to maintain stable intra-abdominal pressure during surgery.
干预措施: AirSeal Robotic Solution (Device)
Standard-pressure pneumoperitoneum
Participants who are assigned to this arm will receive 15 mmHg pneumoperitoneum using the conventional insufflation machine at New York-Presbyterian/Weill Cornell Medical Center.
干预措施: Standard-pressure pneumoperitoneum (15 mmHg) (Other)
结局指标
主要结局
Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order
时间窗: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)
The PACU is the area where participants recover from anesthesia after surgery. The PACU recovery time will be computed in minutes as the interval between the documented PACU arrival timestamp and the documented PACU discharge-order timestamp which will both be abstracted from the institutional electronic medical record. The discharge-order timestamp represents the clinical decision that the participant is fit to leave the PACU and is therefore not confounded by factors such as transport delays.
次要结局
- Average numeric rating scale (NRS) pain score (0-10) at PACU admission(PACU arrival (5 minutes post-surgery))
- Average numeric rating scale (NRS) pain score (0-10) at PACU discharge(PACU discharge (1-4 hours post-surgery))
- Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1)(Post-operative day 1 (24 hours after surgery))
- Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3)(Post-operative day 3 (72 hours after surgery))
- Average morphine milligram equivalents (MME) in the post-anesthesia care unit (PACU)(PACU arrival to PACU discharge (1-4 hours post-surgery))
- Average morphine milligram equivalents (MME) over the first 24-hour post-operative period(Post-operative day 1 (24 hours after surgery))
- Proportion of participants experiencing postoperative nausea or vomiting in the post-anesthesia care unit (PACU)(PACU arrival to PACU discharge (1-4 hours post-surgery))
- Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 1 (POD1)(Post-operative day 1 (24 hours after the surgery))
- Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 3 (POD3)(Post-operative day 3 (72 hours after the surgery))
- Proportion of participants who require intra-operative conversion from robotic-assisted surgery to open surgery(During the surgery (about 60 to 240 minutes))
- Proportion of participants with clinical or radiographic subcutaneous emphysema(From start of surgery to PACU discharge (1-4 hours after surgery))
- Proportion of participants who sustained intraoperative pressure elevation (defined as sustained increase to ≥12 mmHg for ≥10 minutes in the AirSeal arm)(During the surgery (about 60 to 240 minutes))