Dataset Information

Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial.

ABSTRACT:

Background

Higher intraoperative driving pressures (ΔP) are associated with increased postoperative pulmonary complications (PPC). We hypothesised that dynamic adjustment of PEEP throughout abdominal surgery reduces ΔP, maintains positive end-expiratory transpulmonary pressures (P_{tp_ee}) and increases respiratory system static compliance (C_rs) with PEEP levels that are variable between and within patients.

Methods

In a prospective multicentre pilot study, adults at moderate/high risk for PPC undergoing elective abdominal surgery were randomised to one of three ventilation protocols: (1) PEEP≤2 cm H₂O, compared with periodic recruitment manoeuvres followed by individualised PEEP to either optimise respiratory system compliance (PEEP_maxCrs) or maintain positive end-expiratory transpulmonary pressure (PEEP_{Ptp_ee}). The composite primary outcome included intraoperative ΔP, P_{tp_ee}, C_rs, and PEEP values (median (interquartile range) and coefficients of variation [CV_PEEP]).

Results

Thirty-seven patients (48.6% female; age range: 47-73 yr) were assigned to control (PEEP≤2 cm H₂O; n=13), PEEP_maxCrs (n=16), or PEEP_{Ptp_ee} (n=8) groups. The PEEP_{Ptp_ee} intervention could not be delivered in two patients. Subjects assigned to PEEP_maxCrs had lower ΔP (median8 cm H₂O [7-10]), compared with the control group (12 cm H₂O [10-15]; P=0.006). PEEP_maxCrs was also associated with higher P_{tp_ee} (2.0 cm H₂O [-0.7 to 4.5] vs controls: -8.3 cm H₂O [-13.0 to -4.0]; P≤0.001) and higher C_rs (47.7 ml cm H₂O [43.2-68.8] vs controls: 39.0 ml cm H₂O [32.9-43.4]; P=0.009). Individualised PEEP (PEEP_maxCrs and PEEP_{Ptp_ee} combined) varied widely (median: 10 cm H₂O [8-15]; CV_PEEP=0.24 [0.14-0.35]), both between, and within, subjects throughout surgery.

Conclusions

This pilot study suggests that individualised PEEP management strategies applied during abdominal surgery reduce driving pressure, maintain positive P_{tp_ee} and increase static compliance. The wide range of PEEP observed suggests that an individualised approach is required to optimise respiratory mechanics during abdominal surgery.

Clinical trial registration

NCT02671721.

SUBMITTER: Fernandez-Bustamante A

PROVIDER: S-EPMC7497030 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPostoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients' postoperative quality of life, as well as health care costs.Methods/designThis is a multi-center, international, prospective, randomized trial in 380 patients undergoing major abdominal surgery including visceral, urological, and gynecological operations. Eligible patients will be randomly allocated to two treatment arms within the participating centers. Patients of the intervention group will be treated perioperatively following a specific hemodynamic therapy algorithm based on pulse-pressure variation (PPV) and individualized optimization of cardiac output assessed by pulse-contour analysis (ProAQT© device; Pulsion Medical Systems, Feldkirchen, Germany). Patients in the control group will be treated according to standard local care based on established basic hemodynamic treatment. The primary endpoint is a composite comprising the occurrence of moderate or severe postoperative complications or death within 28 days post surgery. Secondary endpoints are: (1) the number of moderate and severe postoperative complications in total, per patient and for each individual complication; (2) the occurrence of at least one of these complications on days 1, 3, 5, 7, and 28 in total and for every complication; (3) the days alive and free of mechanical ventilation, vasopressor therapy and renal replacement therapy, length of intensive care unit, and hospital stay at day 7 and day 28; and (4) mortality and quality of life, assessed by the EQ-5D-5L™ questionnaire, after 6 months.DiscussionThis is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality.Trial registrationTrial registration: NCT03021525 . Registered on 12 January 2017.

Project description:BackgroundMajor abdominal surgery is associated with endothelial glycocalyx disruption. The anti-inflammatory effects of lidocaine were recently associated with endothelial barrier protection.MethodsThis was a single-centre, parallel group, randomized, controlled, double blind, pilot trial. Forty adult patients scheduled for major abdominal surgery were included between December 2016 and March 2017 in the setting of a University Hospital in Brussels (Belgium); reasons for non-inclusion were planned liver resection and conditions associated to increased risk of local anesthetics systemic toxicity. Patients were randomized to receive either lidocaine by continuous intravenous administration or an equivalent volume of 0.9% saline. The primary endpoint was the postoperative syndecan-1 concentration (difference between groups). Near-infrared spectroscopy of the thenar eminence in association with the vascular occlusion test, and contemporary analysis of flow-mediated dilation of the brachial artery were the secondary outcomes, along with haemodynamic data. Blood samples and data were collected before surgery (T0), and at 1-3 h (T1) and 24 h (T2) post-surgery.ResultsSyndecan-1 concentration increased significantly post-surgery (P < 0.001), but without any difference between groups. The near-infrared spectroscopy-derived and flow-mediated dilation-derived variables showed minor changes unrelated to group assignment. Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management. Postoperative lactate concentrations were similar between groups.ConclusionsLidocaine failed to have any effect on endothelial function. Since in comparisons to other types of clinical situations, syndecan-1 was only slightly upregulated, endothelial dysfunction after major abdominal surgery might be overestimated.Trial registration« ISRCTN Registry » identifier: ISRCTN63417725. Date: 15/06/2020. Retrospectively registered.