Dataset Information

Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study.

ABSTRACT:

Background

Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mechanical ventilation mode that delivers assistance to breathe in proportion to the patient's effort. The proportional assistance, called the gain, can be adjusted by the clinician to maintain the patient's respiratory effort or workload within a normal range. Short-term and physiological benefits of this mode compared to pressure support ventilation (PSV) include better patient-ventilator synchrony and a more physiological response to changes in ventilatory demand.

Methods

The objective of this multi-centre randomized controlled trial (RCT) is to determine if, for patients with acute respiratory failure, ventilation with PAV+ will result in a shorter time to successful extubation than with PSV. This multi-centre open-label clinical trial plans to involve approximately 20 sites in several continents. Once eligibility is determined, patients must tolerate a short-term PSV trial and either (1) not meet general weaning criteria or (2) fail a 2-min Zero Continuous Positive Airway Pressure (CPAP) Trial using the rapid shallow breathing index, or (3) fail a spontaneous breathing trial (SBT), in this sequence. Then, participants in this study will be randomized to either PSV or PAV+ in a 1:1 ratio. PAV+ will be set according to a target of muscular pressure. The weaning process will be identical in the two arms. Time to liberation will be the primary outcome; ventilator-free days and other outcomes will be measured.

Discussion

Meta-analyses comparing PAV+ to PSV suggest PAV+ may benefit patients and decrease healthcare costs but no powered study to date has targeted the difficult to wean patient population most likely to benefit from the intervention, or used consistent timing for the implementation of PAV+. Our enrolment strategy, primary outcome measure, and liberation approaches may be useful for studying mechanical ventilation and weaning and can offer important results for patients.

Trial registration

ClinicalTrials.gov NCT02447692 . Prospectively registered on May 19, 2015.

SUBMITTER: Bosma KJ

PROVIDER: S-EPMC10041480 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study.

Bosma Karen J KJ Martin Claudio M CM Burns Karen E A KEA Mancebo Cortes Jordi J Suárez Montero Juan Carlos JC Skrobik Yoanna Y Thorpe Kevin E KE Amaral Andre Carlos Kajdacsy-Balla ACK Arabi Yaseen Y Basmaji John J Beduneau Gaëtan G Beloncle Francois F Carteaux Guillaume G Charbonney Emmanuel E Demoule Alexandre A Dres Martin M Fanelli Vito V Geagea Anna A Goligher Ewan E Lellouche François F Maraffi Tommaso T Mercat Alain A Rodriguez Pablo O PO Shahin Jason J Sibley Stephanie S Spadaro Savino S Vaporidi Katerina K Wilcox M Elizabeth ME Brochard Laurent L

Trials 20230327 1

<h4>Background</h4>Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mechanical ventilation mode that delivers assistance to breathe in proportion to the patient's effort. The proportional assistance, called the gain, can be adjusted by the clinician to maintain the patient's respiratory effort or workload within a normal range. Short-term and physiological benefits of this mode compared to pressure support ventilation (PSV) include better patient-ventilator synchrony ...[more]

PMID: 36973743

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Project description:BackgroundDuring passive mechanical ventilation, the driving pressure of the respiratory system is an important mediator of ventilator-induced lung injury. Monitoring of driving pressure during assisted ventilation, similar to controlled ventilation, could be a tool to identify patients at risk of ventilator-induced lung injury. The aim of this study was to describe driving pressure over time and to identify whether and when high driving pressure occurs in critically ill patients during assisted ventilation.MethodsSixty-two patients fulfilling criteria for assisted ventilation were prospectively studied. Patients were included when the treating physician selected proportional assist ventilation (PAV+), a mode that estimates respiratory system compliance. In these patients, continuous recordings of all ventilator parameters were obtained for up to 72 h. Driving pressure was calculated as tidal volume-to-respiratory system compliance ratio. The distribution of driving pressure and tidal volume values over time was examined, and periods of sustained high driving pressure (≥ 15 cmH2O) and of stable compliance were identified and analyzed.ResultsThe analysis included 3200 h of ventilation, consisting of 8.8 million samples. For most (95%) of the time, driving pressure was < 15 cmH2O and tidal volume < 11 mL/kg (of ideal body weight). In most patients, high driving pressure was observed for short periods of time (median 2.5 min). Prolonged periods of high driving pressure were observed in five patients (8%). During the 661 periods of stable compliance, high driving pressure combined with a tidal volume ≥ 8 mL/kg was observed only in 11 cases (1.6%) pertaining to four patients. High driving pressure occurred almost exclusively when respiratory system compliance was low, and compliance above 30 mL/cmH2O excluded the presence of high driving pressure with 90% sensitivity and specificity.ConclusionsIn critically ill patients fulfilling criteria for assisted ventilation, and ventilated in PAV+ mode, sustained high driving pressure occurred in a small, yet not negligible number of patients. The presence of sustained high driving pressure was not associated with high tidal volume, but occurred almost exclusively when compliance was below 30 mL/cmH2O.

Project description:IntroductionThe objective was to compare the impact of three assistance levels of different modes of mechanical ventilation; neurally adjusted ventilatory assist (NAVA), proportional assist ventilation (PAV), and pressure support ventilation (PSV) on major features of patient-ventilator interaction.MethodsPSV, NAVA, and PAV were set to obtain a tidal volume (VT) of 6 to 8 ml/kg (PSV₁₀₀, NAVA₁₀₀, and PAV₁₀₀) in 16 intubated patients. Assistance was further decreased by 50% (PSV₅₀, NAVA₅₀, and PAV₅₀) and then increased by 50% (PSV₁₅₀, NAVA₁₅₀, and PAV₁₅₀) with all modes. The three modes were randomly applied. Airway flow and pressure, electrical activity of the diaphragm (EAdi), and blood gases were measured. VT, peak EAdi, coefficient of variation of VT and EAdi, and the prevalence of the main patient-ventilator asynchronies were calculated.ResultsPAV and NAVA prevented the increase of VT with high levels of assistance (median 7.4 (interquartile range (IQR) 5.7 to 10.1) ml/kg and 7.4 (IQR, 5.9 to 10.5) ml/kg with PAV₁₅₀ and NAVA₁₅₀ versus 10.9 (IQR, 8.9 to 12.0) ml/kg with PSV₁₅₀, P <0.05). EAdi was higher with PAV than with PSV at level₁₀₀ and level₁₅₀. The coefficient of variation of VT was higher with NAVA and PAV (19 (IQR, 14 to 31)% and 21 (IQR 16 to 29)% with NAVA₁₀₀ and PAV₁₀₀ versus 13 (IQR 11 to 18)% with PSV₁₀₀, P <0.05). The prevalence of ineffective triggering was lower with PAV and NAVA than with PSV (P <0.05), but the prevalence of double triggering was higher with NAVA than with PAV and PSV (P <0.05).ConclusionsPAV and NAVA both prevent overdistention, improve neuromechanical coupling, restore the variability of the breathing pattern, and decrease patient-ventilator asynchrony in fairly similar ways compared with PSV. Further studies are needed to evaluate the possible clinical benefits of NAVA and PAV on clinical outcomes.Trial registrationClinicaltrials.gov NCT02056093 . Registered 18 December 2013.

Project description:BackgroundPostoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery.DesignThe MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen <200 mmHg at 1 hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge.DiscussionThe MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, with a primary composite outcome including death, respiratory failure and postoperative pneumonia.Trial registrationClinicalTrials.gov, NCT03098524 . Registered on 27 February 2017.

Project description:BackgroundThere is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different strategies of mechanical ventilation during cardiopulmonary bypass on postoperative pulmonary function and complications.Methods/designThe CPBVENT study is a single-blind, multicenter, randomized controlled trial. We are going to enroll 870 patients undergoing elective cardiac surgery with planned use of cardiopulmonary bypass. Patients will be randomized into three groups: (1) no mechanical ventilation during cardiopulmonary bypass, (2) continuous positive airway pressure of 5 cmH2O during cardiopulmonary bypass, (3) respiratory rate of 5 acts/min with a tidal volume of 2-3 ml/Kg of ideal body weight and positive end-expiratory pressure of 3-5 cmH2O during cardiopulmonary bypass. The primary endpoint will be the incidence of a PaO2/FiO2 ratio <200 until the time of discharge from the intensive care unit. The secondary endpoints will be the incidence of postoperative pulmonary complications and 30-day mortality. Patients will be followed-up for 12 months after the date of randomization.DiscussionThe CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery.Trial registrationClinicalTrials.gov, ID: NCT02090205 . Registered on 8 March 2014.

Dataset Information

Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study.

Background

Methods

Discussion

Trial registration

Publications

Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study.

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