Akdeniz University Hospital
Antalya, (532) 256-8442, Turkey (Türkiye)
NCT Number: NCT07766603
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.
Trial opening soon.
Get Notified40 year and older
Male
Interventional
Not applicable
Antalya, (532) 256-8442, Turkey (Türkiye)
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.
Postoperative delirium will be evaluated during the first 48 hours after surgery. The 4AT will be administered at approximately 24 and 48 hours after surgery, and the Nursing Delirium Screening Scale (Nu-DESC) will be used during the first 12 postoperative hours and again during the 24-48-hour postoperative period. A 4AT score of 4 or greater and/or a Nu-DESC score of 2 or greater will be considered indicative of delirium for the purposes of the study.
Secondary clinical assessments will include 4AT and Nu-DESC scores, postoperative peripheral oxygen saturation, supplemental oxygen requirement, postoperative hypoxemia, clinically documented pulmonary complications or atelectasis, postoperative pain, nausea and vomiting, additional analgesic requirement, intensive care requirement, and length of hospital stay.
No additional medication, invasive procedure, blood sampling, laboratory testing, imaging, or medical device assessment will be performed solely for research purposes. All anesthesia, surgery, treatment, and postoperative care will follow routine clinical practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive standardized, device-free deep breathing exercise training during the preoperative period. In an upright or semi-upright position, participants will be instructed to 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. Participants will be asked to perform three sessions per day from the time of training until surgery. Exercise adherence will be documented using a home follow-up form and reviewed on the morning of surgery.
Time frame: 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.
Time frame: At 24 and 48 hours postoperatively
The 4AT will be used to assess postoperative delirium-related symptoms. The total score ranges from 0 to 12, with higher scores indicating greater likelihood of delirium. A score ≥4 indicates a high likelihood of delirium. Scores will be recorded at 24 and 48 hours after surgery.
Time frame: During the first 12 postoperative hours and during the 24-48-hour postoperative period
The Nu-DESC will be used to assess postoperative delirium-related symptoms. The total score ranges from 0 to 10, with higher scores indicating more delirium-related symptoms. A score ≥2 indicates a high likelihood of delirium.
Time frame: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Peripheral oxygen saturation (SpO₂), expressed as a percentage, will be recorded from routine clinical monitoring at predefined postoperative time points.
Time frame: From the PACU/early postoperative period through 48 hours postoperatively
The need for supplemental oxygen will be recorded at predefined postoperative assessments. The number and proportion of participants requiring supplemental oxygen will be compared between study groups.
Time frame: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Postoperative pain intensity will be assessed using a 0-10 Numerical Rating Scale/Visual Analog Scale (NRS/VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Contact information is provided by the study sponsor or research team.
ALİ DEMİRTAŞ
Other
Effect of Preoperative Breathing Exercise Training on Postoperative Delirium in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Pilot Study
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