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

NCT01514331 | Completed

• 1 other identifier: 01/2011-68
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress, Newborn; Ventilator Induced Lung Injury

Keywords

Ventilator Induced Lung Injury; Neonatal respiratory distress; Mechanical ventilation

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (8)

• bronchopulmonary dysplasia

  36 weeks corrected age

• patent ductus arteriosus

  in the first week of post natal life of the patient

• necrotizing enterocolitis

  36 weeks corrected age

• intraventricular hemorrhage

  during first week

• pneumothorax

  during first 3 days

Study Arms (2)

PSV+VG

ACTIVE COMPARATOR

Neonates who require mechanical ventilation and randomised to pressure support + volume guarantee (PSV+VG) mode

Other: PSV+VG (pressure support ventilation+volume guarantee)

SIMV+VG

ACTIVE COMPARATOR

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)

Interventions

SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee) OTHER

Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode

Also known as: SIMV + VG mode of ventilation

SIMV+VG

PSV+VG (pressure support ventilation+volume guarantee) OTHER

Neonates who need mechanical ventilation will be ventilated with PSV+VG

Also known as: PSV+ VG mode of ventilation

PSV+VG

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• neonates who need mechanical ventilation other than conventional ventilation

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine

Beşevler, Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Injury

Study Officials

• Ebru N Ergenekon, MD

  Gazi University, Division of newborn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 23, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

TU (1)