Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine
Beşevler, Ankara, 06500, Turkey (Türkiye)
NCT Number: NCT01514331
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.
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All sexes
Interventional
Not applicable
Beşevler, Ankara, 06500, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode
Other names: SIMV + VG mode of ventilation
Neonates who need mechanical ventilation will be ventilated with PSV+VG
Other names: PSV+ VG mode of ventilation
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
variability in tidal volume measured with babyview program
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
variability in peak inspiratory pressure measured with babyview program
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
changes in respiratory rate, tacypnea rate
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
changes in oxygen saturation, desaturation rate, hyperoxy rate
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hypocarbic blood gases and least pCo2 level
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hypercarbic blood gases and highest pCo2 level
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hypoxic blood gases and least pO2 level
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hyperoxic blood gases and highest pO2 level
Time frame: 36 weeks corrected age
Oxygen requirement at 36 weeks corrected age
Time frame: 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
Time frame: 36 weeks corrected age
Necrotising entercolitis defined by clinical and radiological findings
Time frame: during first week
Intraventricular hemorrhage diagnosed by head ultrasound
Time frame: during first 3 days
Air leak diagnosed by chest x-ray
Time frame: during first week
Air leak diagnosed by x-ray
Time frame: during first week
Time frame: until 36 weeks corrected age
Retinal disease diagnosed by indirect opthtalmoscopic exam
Gazi University
Other
Determination of Ventilatory Parameters and Inflammatory Responses of Neonates Who Are Ventilated by Volume Guarantee Combined With Synchronized Intermittent Mandatory Ventilation or Pressure Support Ventilation
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