Clinical Trials Logo

Clinical Trial Summary

OBJECTIVES: The trunk inclination from semirecumbent to lying supine improves lung mechanics and reduces end-expiratory lung volume in Acute Respiratory Distress Syndrome (ARDS) patients. Besides, it can improve the ventilatory ratio and PaCO2, although the effects and mechanisms are not entirely elucidated. Therefore, this study aimed to evaluate the effects of trunk tilt from 45° to 10° on CO2 removal efficiency. DESIGN: Quasi-experimental study. SETTING: A medical ICU in Chile. PATIENTS: Twenty-two patients with ARDS. INTERVENTION: Patients in pressure-controlled ventilation underwent three 60-minute steps in which trunk inclination was changed from 45° (baseline) to 10° (intervention) and back to 45° (control) in the last step. Respiratory mechanics, arterial blood gas analysis, dead space by volumetric capnography, and electrical impedance tomography were recorded.


Clinical Trial Description

The role of trunk inclination in the lying position and its physiological effects have been extensively studied in patients with acute respiratory distress syndrome (ARDS). Consistently, driving pressure and respiratory system compliance (CRS) increase has been found when bed angulation is increased at 40 - 45 degrees. Besides, most patients in the semi-recumbent position rising end-expiratory lung volume (EELV) and oxygenation. These findings continue to raise questions regarding the physiological mechanisms underlying these effects. On the other side, changing trunk tilt to zero degrees in patients with COVID-19 related ARDS reduced the ventilatory ratio and partial pressure of carbon dioxide (PaCO2). In addition, when patients were placed in a lying-flat position at 0°, the driving pressure and lung compliance declined, generating lower energy applied to the lung. This way, an alveolar overdistention reduction could explain the improvement in the kinetics of CO2 but is not fully elucidated, mainly due to the short evaluation period and the low accuracy of the ventilatory ratio to measure the lung efficiency to exhale CO2. It should be noted that one of the best ways to assess ventilatory efficiency physiologically is with volumetric capnography (8), but this technology has never been used when chest inclination changes in ARDS patients. Thus, we hypothesized that changes in trunk inclination to a lying-flat position in ARDS patients connected to mechanical ventilation would improve CO2 removal efficiency. Therefore, the primary objective of this study was to assess the effects of postural change from 45° to 10° bed tilt on CO2 exhaled per minute (VCO2), Bohr's dead space (VDBohr/VT) and PaCO2. The secondary objective was to evaluate the lung volume effects and the ventilation distribution in the different lung regions. Study steps: step I: Baseline conditions. Patient in the semi-recumbent position at 45° head-up, and lower extremities parallel to the floor. step II: Intervention phase with a trunk postural change at 10° in lying supine position. step III: Control phase with a return to the semi-recumbent position at 45° head-up. Five minutes before each step, PaCO2, and partial pressure of arterial oxygen over the fraction of inspired oxygen (PaO2/FIO2) were recorded. Both tidal volume (VT), volumetric capnography and Electrical impedance tomography (EIT) variables were analyzed offline using the mean value of the last 20 breaths of the last three minutes of each step. Haemodynamic variables and pulse oximetry were continuously monitored (Multiparameter Spacelabs 91393 Xprezzon®). Security procedure: Therapeutic interventions were kept strictly unchanged during all evaluation periods. The following criteria were predefined to interrupt the study protocol if required: desaturation corresponding to a drop of more than 10% of baseline oxygen saturation value; drop in mean arterial pressure of more than 20% of baseline value or heart rate increase of more than 20 % of baseline values. Primary outcomes: VDBohr/VT and PaCO2 reduction at 60 minutes of trunk change to 10° concerning the body position in basal conditions of 45°. Statistical analysis: Different assumptions were made for a repeated sample study. We considered as clinically significant effect, a mean reduction of 5 mmHg with a standard deviation of ± 3 mmHg of PaCO2 with a power of 90% and a probability of type I error of 0.01. Based on these assumptions, the sample size was 22 participants. The Shapiro-Wilk test was performed to determine the distribution of continuous variables while homoscedasticity was tested using the Levene test. According to their distribution, continuous variables were expressed as mean and standard deviation or median and interquartile range. Parametric versus non-parametric tests were decided according to the data distribution and whether the assumption of normality was met. Continuous variables were analyzed by ANOVA for repeat measure, or the Friedman test was applied, as appropriate. Bonferroni and Dunn's post hoc were used for the comparison between step II-step I, step III-step I and step III-step II, respectively. T-test was used to measure the median difference and 95% confidence interval (95% CI) between step I and step II. Wilcoxon rank test was performed to evaluate changes in ventral or dorsal end-expiratory lung impedance (EELI) and tidal variation of impedance (VTI) from 45 to 10 degrees. A two-tailed p-value less than 0.05 was considered statistically significant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05281536
Study type Interventional
Source Clinica las Condes, Chile
Contact
Status Completed
Phase N/A
Start date April 1, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT04435613 - Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients N/A
Enrolling by invitation NCT05020210 - Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Completed NCT04468971 - REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia Phase 1
Completed NCT04505592 - Tenecteplase in Patients With COVID-19 Phase 2
Completed NCT04493242 - Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Completed NCT01949272 - Optimization of PEEP for Alveolar Recruitment in ARDS N/A
Not yet recruiting NCT01668368 - Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance N/A
Completed NCT01881061 - Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit N/A
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Completed NCT05035589 - The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Recruiting NCT04764032 - Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Completed NCT04556513 - Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
Recruiting NCT06036056 - NMR Based Metabolomics Kinetics in ARDS Patients
Recruiting NCT04503876 - Effects of End-expiratory Positive Pressure Optimization in Intubated Patients With Healthy Lung or Acute Respiratory Distress Syndrome N/A
Recruiting NCT04643691 - Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS Phase 2
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Not yet recruiting NCT05341687 - Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
Recruiting NCT05056090 - Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome. N/A