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Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial.

ABSTRACT: Robot-assisted laparoscopic radical prostatectomy and robot-assisted radical cystectomy have gradually become the preferred choices for urologists as they allow surgeons to perform complex procedures more precisely and effectively. The pneumoperitoneum, which is normally applied in these surgeries to provide visual clarity and space to perform the procedure, may cause hemodynamic disturbance, potentially myocardial injury. Thus surgeons have recently considered opting for the low-pressure pneumoperitoneum to lower this negative impact. Herein we describe a protocol for a clinical trial to compare the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery.This study is designed to be a bicenter clinical trial. In total 280 patients scheduled to undergo robot-assisted laparoscopic radical prostatectomy or robot-assisted radical cystectomy will be enrolled and randomized into two groups, with standard- (12-16 mmHg) and low-pressure (7-10 mmHg) pneumoperitoneum, respectively. Troponin T will be measured as the primary endpoint to assess the extent of myocardial injury. Nt-proBNP and hemodynamic indexes will also be recorded for further analysis.The significance of this study is emphasized by the fact that there are few studies that have focused on the impact of prolonged pneumoperitoneum on myocardial injury, which is relevant to postoperative mortality. We hope that the conclusions drawn from this study could provide reference and basis to the future of the pneumoperitoneum in clinical practice.Registered at https://www.clinicaltrials.gov with the Identifier NCT02600481 on November 5, 2015.

SUBMITTER: Zhang X

PROVIDER: S-EPMC5057242 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial.

Zhang Xixue X Wei Jionglin J Song Xiaoxing X Zhang Yuhao Y Qian Weiqing W Sheng Lu L Shen Zhoujun Z Yang Lvjun L Dong Rong R Gu Weidong W

Trials 20161010 1

<h4>Background</h4>Robot-assisted laparoscopic radical prostatectomy and robot-assisted radical cystectomy have gradually become the preferred choices for urologists as they allow surgeons to perform complex procedures more precisely and effectively. The pneumoperitoneum, which is normally applied in these surgeries to provide visual clarity and space to perform the procedure, may cause hemodynamic disturbance, potentially myocardial injury. Thus surgeons have recently considered opting for the ...[more]

PMID: 27724965

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Project description:BACKGROUND:The aim of this study was to investigate the effect of the steep Trendelenburg position (STP) with pneumoperitoneum on whole-blood viscosity (WBV) in patients undergoing robot-assisted laparoscopic prostatectomy (RALP). The study also analyzed the associations of clinical patient-specific and time-dependent variables with WBV and recorded postoperative outcomes. METHODS:Fifty-eight adult male patients (ASA physical status of I or II) undergoing elective RALP were prospectively analyzed in this study. WBV was intraoperatively measured three times: at the beginning of surgery in the supine position without pneumoperitoneum; after 30?min in the STP with pneumoperitoneum; and at the end of surgery in the supine position without pneumoperitoneum. The WBV at a high shear rate (300?s-?1) was recorded as systolic blood viscosity (SBV) and that at a low shear rate (5?s-?1) was recorded as diastolic blood viscosity (DBV). Systolic blood hyperviscosity was defined as >?13.0?cP at 300?s-?1 and diastolic blood hyperviscosity was defined as >?4.1?cP at 5?s-?1. RESULTS:The WBV and incidences of systolic and diastolic blood hyperviscosity significantly increased from the supine position without pneumoperitoneum to the STP with pneumoperitoneum. When RALP was performed in the STP with pneumoperitoneum, 12 patients (27.3%) who had normal SBV at the beginning of surgery and 11 patients (26.8%) who had normal DBV at the beginning of surgery developed new systolic and diastolic blood hyperviscosity, respectively. The degree of increase in WBV after positioning with the STP and pneumoperitoneum was higher in the patients with hyperviscosity than in those without hyperviscosity at the beginning of surgery. Higher preoperative body mass index (BMI) and hematocrit level were associated with the development of both systolic and diastolic blood hyperviscosity in the STP with pneumoperitoneum. All patients were postoperatively discharged without fatal complications. CONCLUSIONS:Changes in surgical position may influence WBV, and higher preoperative BMI and hematocrit level are independent factors associated with the risk of hyperviscosity during RALP in the STP with pneumoperitoneum. TRIAL REGISTRATION:Clinical Research Information Service, Republic of Korea, approval number: KCT0003295 on October 25, 2018.

Project description:BACKGROUND:The reliability of pulse pressure variation (PPV) and stroke volume variation (SVV) is controversial under pneumoperitoneum. In addition, the usefulness of these indices is being called into question with the increasing adoption of lung-protective ventilation using low tidal volume (VT) in surgical patients. A recent study indicated that changes in PPV or SVV obtained by transiently increasing VT (VT challenge) accurately predicted fluid responsiveness even in critically ill patients receiving low VT. We evaluated whether the changes in PPV and SVV induced by a VT challenge predicted fluid responsiveness during pneumoperitoneum. METHODS:We performed an interventional prospective study in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. PPV, SVV, and the stroke volume index (SVI) were measured at a VT of 6?mL/kg and 3?min after increasing the VT to 8?mL/kg. The VT was reduced to 6?mL/kg, and measurements were performed before and 5?min after volume expansion (infusing 6% hydroxyethyl starch 6?ml/kg over 10?min). Fluid responsiveness was defined as ?15% increase in the SVI. RESULTS:Twenty-four of the 38 patients enrolled in the study were responders. In the receiver operating characteristic curve analysis, an increase in PPV?>?1% after the VT challenge showed excellent predictive capability for fluid responsiveness, with an area under the curve (AUC) of 0.95 [95% confidence interval (CI), 0.83-0.99, P <?0.0001; sensitivity 92%, specificity 86%]. An increase in SVV?>?2% after the VT challenge predicted fluid responsiveness, but showed only fair predictive capability, with an AUC of 0.76 (95% CI, 0.60-0.89, P <?0.0006; sensitivity 46%, specificity 100%). The augmented values of PPV and SVV following VT challenge also showed the improved predictability of fluid responsiveness compared to PPV and SVV values (as measured by VT) of 6?ml/kg. CONCLUSIONS:The change in PPV following the VT challenge has excellent reliability in predicting fluid responsiveness in our surgical population. The change in SVV and augmented values of PPV and SVV following this test are also reliable. TRIAL REGISTRATION:This trial was registered with Clinicaltrials.gov, NCT03467711 , 10th March 2018.

Project description:BackgroundDuring robotic gynecologic pneumoperitoneum surgery in the Trendelenburg position, aeration loss leads to perioperative atelectasis. Recently developed ventilator mode pressure-controlled ventilation volume-guaranteed (PCV-VG) mode could provide adequate ventilation with lower inspiratory pressure compared to volume-controlled ventilation (VCV); we hypothesized that PCV-VG mode may be beneficial in reducing perioperative atelectasis via low tidal volume (VT) of 6 mL/kg ventilation during robotic gynecologic pneumoperitoneum surgery in the Trendelenburg position. We applied lung ultrasound score (LUS) for detecting perioperative atelectasis. We aimed to compare perioperative atelectasis between VCV and PCV-VG with a low VT of 6 mL/kg during pneumoperitoneum surgery in the Trendelenburg position using LUS.MethodsPatients scheduled for robotic gynecologic surgery were randomly allocated to the VCV (n = 41) or PCV-VG group (n = 41). LUS, ventilatory, and hemodynamic parameters were evaluated at T1 (before induction), T2 (10 minutes after induction in the supine position), T3 (10 minutes after desufflation of CO2 in the supine position), and T4 (30 minutes after emergence from anesthesia in the recovery room).ResultsEighty patients (40 with PCV-VG and 40 with VCV) were included. Demographic data showed no significant differences between the groups. The total LUS has changed from baseline to T4, 0.63 (95% confidence interval [CI], 0.32, 0.94) to 1.77 (95% CI, 1.42, 2.21) in the VCV group and 0.86 (95% CI, 0.56, 1.16) to 1.43 (95% CI, 1.08, 1.78) in the PCV-VG group (P = 0.170). In both groups, total LUS increased significantly compared to the baseline values.ConclusionUsing a low VT of 6 mL/kg during pneumoperitoneum surgery in the Trendelenburg position, our study showed no evidence that PCV-VG ventilation was superior to VCV in terms of perioperative atelectasis.Trial registrationClinical Research Information Service Identifier: KCT0006404.

Dataset Information

Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial.

Publications

Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial.

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