Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation

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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Induced Lung Injury; Respiratory Distress, Newborn
• Intervention / Treatment: Other: PSV+VG (pressure support ventilation+volume guarantee); Other: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Besevler, Ankara, Turkey, 06500
      • Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PSV+VG; Neonates who require mechanical ventilation and randomised to pressure support + volume guarantee (PSV+VG) mode	Other: PSV+VG (pressure support ventilation+volume guarantee); Neonates who need mechanical ventilation will be ventilated with PSV+VG; Other Names: PSV+ VG mode of ventilation
Active Comparator: SIMV+VG; Neonates who require mechanical ventilation and randomised to synchronised intermittant mandatory ventilation + volume guarantee (SIMV+VG) mode	Other: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee); Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode; Other Names: SIMV + VG mode of ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-1beta levels in tracheal aspirate material	Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported	Baseline and 72 hours of mechanical ventilation
IL-6 level in tracheal aspirate	Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported	Baseline and 72 hours of mechanical ventilation
IL-8 in tracheal aspirate material	Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported	Baseline and 72 hours of mechanical ventilation
IL-10 level in tracheal aspirate material	Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported	Baseline and 72 hours of mechanical ventilation
TNF alfa in tracheal aspirate material	Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported	Baseline and 72 hours of mechanical ventilation
tidal volume variability	variability in tidal volume measured with babyview program	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
peak inspiratory pressure variability	variability in peak inspiratory pressure measured with babyview program	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
respiratory rate variability	changes in respiratory rate, tacypnea rate	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
oxygen saturation variability	changes in oxygen saturation, desaturation rate, hyperoxy rate	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
lowest carbondioxide level (mmHg)	ratio of hypocarbic blood gases and least pCo2 level	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
highest carbondioxide level (mmHg)	ratio of hypercarbic blood gases and highest pCo2 level	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
lowest oxygen level (mmHg)	ratio of hypoxic blood gases and least pO2 level	72 hours of mechanical ventilation or entire ventilation time if extubated earlier
highest oxygen level (mmHg)	ratio of hyperoxic blood gases and highest pO2 level	72 hours of mechanical ventilation or entire ventilation time if extubated earlier

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bronchopulmonary dysplasia	Oxygen requirement at 36 weeks corrected age	36 weeks corrected age
patent ductus arteriosus	Presence of hemodynamically significant patent ductus arteriosus in the first 7 days of life	in the first week of post natal life of the patient
necrotizing enterocolitis	Necrotising entercolitis defined by clinical and radiological findings	36 weeks corrected age
intraventricular hemorrhage	Intraventricular hemorrhage diagnosed by head ultrasound	during first week
pneumothorax	Air leak diagnosed by chest x-ray	during first 3 days
pulmonary interstitial emphysema	Air leak diagnosed by x-ray	during first week
pulmonary hemorrhage		during first week
retinopathy of prematurity	Retinal disease diagnosed by indirect opthtalmoscopic exam	until 36 weeks corrected age

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Ebru N Ergenekon, MD, Gazi University, Division of newborn Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Neonatal respiratory distress; Ventilator Induced Lung Injury
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 01/2011-68