Respiratory Distress, Newborn, Ventilator Induced Lung Injury
Conditions
Keywords
Ventilator Induced Lung Injury, Neonatal respiratory distress, Mechanical ventilation
Brief summary
The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.
Detailed description
Term or preterm neonates may need mechanical ventilation due to different etiologies. In all patients aim of mechanical ventilation is to promote pulmonary gas exchange, reduce the respiratory work of patient. Ideal mechanical ventilation must minimize pulmonary trauma with low inspiratory pressures that obtains adequate and constant tidal volumes. Ventilation associated pulmonary injury is an important subject that must be considered during mechanical ventilation. Atelectotrauma, volutrauma, barotrauma and biotrauma must be monitored. Volutrauma, barotrauma and oxygen toxicity cause cytokine increase that results in biotrauma. This parenchymal inflammation is a risk factor for chronic lung disease which is an important morbidity of ventilated neonates. From past to present neonates were ventilated with different ventilation modes including IMV (Intermittent Mandatory Ventilation), SIMV, A/C (Assist Control Ventilation), PSV,HFV (High Frequency Ventilation). Both PSV and SIMV are patient trigger ventilation modes but SIMV is a time cycled and PSV is a flow cycled mode. In recent years hybrid techniques were developed to combine beneficial features of volume and pressure limited ventilation. In commercial ventilation devices these techniques have different names as volume guaranteed pressure limited ventilation (Drager Babylog 8000), pressure regulated volume controlled ventilation (Siemens servo 3000), volume guaranteed pressure support ventilation (VIP Bird Gold). Since there is not a standard protocol for mechanical ventilation of neonates different countries and even different NICU's use different ventilation protocols. Literature supports volume targetted ventilation to reduce barotrauma with low maximum inspiratory pressures and to reduce volutrauma with constant tidal volumes. When A/C+VG and SIMV+VG were compared in a crossover trial, more constant tidal volumes were obtained in A/C mode. Inflammatory cytokines have also been measured in different groups of patients with variable ventilatory management techniques. So far there has not been a randomized study published comparing VG+SIMV with VG+PSV in newborns with regards to tidal volume , peak inspiratory pressure variability,or inflammatory cytokines. Therefore in this study the investigators aimed to compare these two ventilation modes with regards to short term outcome.
Interventions
OTHERSIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)
Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode
OTHERPSV+VG (pressure support ventilation+volume guarantee)
Neonates who need mechanical ventilation will be ventilated with PSV+VG
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
* neonates with respiratory distress who need mechanical ventilation * gestational age less than or equal to 37 weeks * neonates who need mechanical ventilation within first 24 hours
Exclusion criteria
* neonates who need mechanical ventilation other than conventional ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| highest oxygen level (mmHg) | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | ratio of hyperoxic blood gases and highest pO2 level |
| TNF alfa in tracheal aspirate material | Baseline and 72 hours of mechanical ventilation | Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported |
| tidal volume variability | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | variability in tidal volume measured with babyview program |
| peak inspiratory pressure variability | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | variability in peak inspiratory pressure measured with babyview program |
| respiratory rate variability | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | changes in respiratory rate, tacypnea rate |
| oxygen saturation variability | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | changes in oxygen saturation, desaturation rate, hyperoxy rate |
| lowest carbondioxide level (mmHg) | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | ratio of hypocarbic blood gases and least pCo2 level |
| highest carbondioxide level (mmHg) | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | ratio of hypercarbic blood gases and highest pCo2 level |
| lowest oxygen level (mmHg) | 72 hours of mechanical ventilation or entire ventilation time if extubated earlier | ratio of hypoxic blood gases and least pO2 level |
| IL-1beta levels in tracheal aspirate material | Baseline and 72 hours of mechanical ventilation | Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported |
| IL-6 level in tracheal aspirate | Baseline and 72 hours of mechanical ventilation | Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported |
| IL-8 in tracheal aspirate material | Baseline and 72 hours of mechanical ventilation | Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported |
| IL-10 level in tracheal aspirate material | Baseline and 72 hours of mechanical ventilation | Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bronchopulmonary dysplasia | 36 weeks corrected age | Oxygen requirement at 36 weeks corrected age |
| patent ductus arteriosus | in the first week of post natal life of the patient | Presence of hemodynamically significant patent ductus arteriosus in the first 7 days of life |
| necrotizing enterocolitis | 36 weeks corrected age | Necrotising entercolitis defined by clinical and radiological findings |
| intraventricular hemorrhage | during first week | Intraventricular hemorrhage diagnosed by head ultrasound |
| pneumothorax | during first 3 days | Air leak diagnosed by chest x-ray |
| pulmonary interstitial emphysema | during first week | Air leak diagnosed by x-ray |
| pulmonary hemorrhage | during first week | — |
| retinopathy of prematurity | until 36 weeks corrected age | Retinal disease diagnosed by indirect opthtalmoscopic exam |
Countries
Turkey (Türkiye)
Outcome results
None listed