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Completed

NCT Number: NCT01514331

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

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Key information

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beşevler, Ankara, 06500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Other names: SIMV + VG mode of ventilation

PSV+VG (pressure support ventilation+volume guarantee)

Other

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

Other names: PSV+ VG mode of ventilation

Primary outcomes

  1. IL-1beta levels in tracheal aspirate material

    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

  2. IL-6 level in tracheal aspirate

    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

  3. IL-8 in tracheal aspirate material

    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

  4. IL-10 level in tracheal aspirate material

    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

  5. TNF alfa in tracheal aspirate material

    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

  6. tidal volume variability

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    variability in tidal volume measured with babyview program

  7. peak inspiratory pressure variability

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    variability in peak inspiratory pressure measured with babyview program

  8. respiratory rate variability

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    changes in respiratory rate, tacypnea rate

  9. oxygen saturation variability

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    changes in oxygen saturation, desaturation rate, hyperoxy rate

  10. lowest carbondioxide level (mmHg)

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    ratio of hypocarbic blood gases and least pCo2 level

  11. highest carbondioxide level (mmHg)

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    ratio of hypercarbic blood gases and highest pCo2 level

  12. lowest oxygen level (mmHg)

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    ratio of hypoxic blood gases and least pO2 level

  13. highest oxygen level (mmHg)

    Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

    ratio of hyperoxic blood gases and highest pO2 level

Secondary outcomes

  1. bronchopulmonary dysplasia

    Time frame: 36 weeks corrected age

    Oxygen requirement at 36 weeks corrected age

  2. patent ductus arteriosus

    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

  3. necrotizing enterocolitis

    Time frame: 36 weeks corrected age

    Necrotising entercolitis defined by clinical and radiological findings

  4. intraventricular hemorrhage

    Time frame: during first week

    Intraventricular hemorrhage diagnosed by head ultrasound

  5. pneumothorax

    Time frame: during first 3 days

    Air leak diagnosed by chest x-ray

  6. pulmonary interstitial emphysema

    Time frame: during first week

    Air leak diagnosed by x-ray

  7. pulmonary hemorrhage

    Time frame: during first week

  8. retinopathy of prematurity

    Time frame: until 36 weeks corrected age

    Retinal disease diagnosed by indirect opthtalmoscopic exam

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2012
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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