Effect of Preoperative Breathing Exercise Training on Postoperative Delirium in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Delirium Within 48 Hours After Surgery
研究概览
简要总结
Postoperative delirium is an acute and fluctuating disturbance in attention, awareness, and thinking that may occur after major surgery. Patients undergoing robot-assisted radical prostatectomy may be at risk because of factors such as older age, general anesthesia, prolonged surgery, pneumoperitoneum, and steep Trendelenburg positioning.
This single-center, prospective, two-arm controlled pilot study will evaluate whether preoperative deep breathing exercise training is associated with a lower occurrence of postoperative delirium in patients undergoing elective robot-assisted radical prostatectomy. A total of 50 patients will be included, with 25 patients in the breathing exercise training group and 25 patients in the control group.
Patients in the breathing exercise training group will receive standardized, device-free deep breathing exercise instruction during the preoperative period, usually approximately one week before surgery. They will be asked to perform three sessions per day until surgery, with 10 deep breaths in each session. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.
Postoperative delirium will be assessed during the first 48 hours after surgery using the 4AT and Nursing Delirium Screening Scale (Nu-DESC). The study will also evaluate postoperative oxygenation, oxygen requirement, pain, nausea and vomiting, respiratory complications, intensive care requirement, and length of hospital stay. The study will not alter routine anesthesia, surgery, or postoperative treatment, and no additional invasive procedures, laboratory tests, or imaging will be performed for research purposes.
详细描述
Robot-assisted radical prostatectomy (RARP) is a commonly performed minimally invasive surgical procedure for the treatment of prostate cancer. In this population, perioperative factors including advanced age, comorbidities, general anesthesia, pneumoperitoneum, prolonged surgical and anesthetic duration, and steep Trendelenburg positioning may contribute to postoperative respiratory changes and postoperative delirium. Postoperative delirium is characterized by an acute and fluctuating disturbance in attention, awareness, and cognitive function and may be associated with increased complications, prolonged hospitalization, and greater care requirements.
Preoperative breathing exercise training is a noninvasive, nonpharmacological, and low-cost intervention intended to encourage slow, controlled, and deep breathing. Improving patients' familiarity and adherence to breathing exercises before surgery may facilitate postoperative respiratory exercises and may contribute to preservation of oxygenation and reduction of postoperative respiratory complications. These effects may also influence clinical factors associated with postoperative delirium. Evidence regarding the relationship between preoperative breathing exercise training and postoperative delirium specifically in patients undergoing RARP remains limited.
This study is designed as a single-center, prospective, two-arm controlled pilot study and will include 50 male patients aged 40 years or older who are scheduled for elective RARP. Twenty-five patients will be included in the preoperative breathing exercise training group and 25 patients in the control group.
Patients in the intervention group will receive standardized deep breathing exercise training during the preoperative outpatient evaluation, generally approximately one week before surgery. Patients will be instructed to sit in an upright or semi-upright position, relax their shoulders, inhale slowly and deeply through the nose, hold their breath for approximately 2-3 seconds, and then exhale slowly through the mouth. Each session will consist of 10 deep breaths. Patients will be asked to perform the exercises three times daily until the day of surgery. Adherence will be recorded using a home breathing exercise follow-up form and reviewed on the morning of surgery. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.
Routine perioperative anesthesia and surgical management will not be modified because of study participation. Intraoperative variables including anesthesia and surgical duration, pneumoperitoneum duration, Trendelenburg duration when available, oxygen saturation, end-tidal carbon dioxide, intraoperative hypotension, vasopressor or inotrope requirement, estimated blood loss, fluid administration, transfusion, and perioperative complications will be recorded from routine clinical and anesthesia records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40 years or older.
- •Scheduled to undergo elective robot-assisted radical prostatectomy (RARP) at -Akdeniz University Hospital.
- •Able to communicate and suitable for preoperative and postoperative -cognitive/delirium assessment using the 4AT and Nu-DESC.
- •Able and willing to provide written informed consent.
- •Availability of clinical follow-up data during the first 48 postoperative hours.
排除标准
- •Refusal to participate or withdrawal of informed consent.
- •History of delirium, severe dementia, severe cognitive impairment, or an active neurological disorder that would interfere with delirium assessment.
- •Active psychosis, severe psychiatric disease, or use of psychoactive medication that could substantially affect cognitive assessment.
- •Level of consciousness not allowing assessment, or severe hearing or speech impairment preventing adequate communication.
- •Emergency surgery or failure to complete the planned procedure as robot-assisted radical prostatectomy.
- •Inability to complete the postoperative 4AT and/or Nu-DESC assessments or substantial missing data affecting the primary analysis.
- •Inability to tolerate the breathing exercises or insufficient home exercise adherence/follow-up data for the planned analysis.
研究组 & 干预措施
Control
Participants randomized to this arm will receive routine preoperative information and standard perioperative care without additional structured preoperative breathing exercise training.
Preoperative Breathing Exercise Training
Participants randomized to this arm will receive standardized preoperative deep breathing exercise training, generally approximately one week before surgery. They will be instructed to perform the exercises three times daily until the day of surgery, with 10 deep breaths in each session. Adherence will be recorded using a home breathing exercise follow-up form.
干预措施: Preoperative Deep Breathing Exercise Training (Behavioral)
结局指标
主要结局
Number of Participants With Postoperative Delirium Within 48 Hours After Surgery
时间窗: From the end of surgery through 48 hours postoperatively
Postoperative delirium will be defined as a 4AT score ≥4 and/or a Nursing Delirium Screening Scale (Nu-DESC) score ≥2 at any prespecified assessment during the first 48 hours after surgery. The 4AT will be assessed at 24 and 48 hours postoperatively, and the Nu-DESC will be assessed during the first 12 postoperative hours and again during the 24-48-hour postoperative period. The outcome will be reported as the number and proportion of participants who develop postoperative delirium.
次要结局
- 4AT Delirium Screening Score(At 24 and 48 hours postoperatively)
- Nursing Delirium Screening Scale (Nu-DESC) Score(During the first 12 postoperative hours and during the 24-48-hour postoperative period)
- Peripheral Oxygen Saturation (SpO₂) at Predefined Postoperative Time Points(PACU/early postoperative period and at 6, 24, and 48 hours postoperatively)
- Number of Participants Requiring Supplemental Oxygen Postoperatively(From the PACU/early postoperative period through 48 hours postoperatively)
- Postoperative Pain Score on the NRS/VAS(PACU/early postoperative period and at 6, 24, and 48 hours postoperatively)
研究者
ALİ DEMİRTAŞ
Lecturer
Akdeniz University Hospital
