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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ebru Ergenekon, Gazi University
ClinicalTrials.gov Identifier:
NCT01514331
First received: December 20, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Respiratory Distress, Newborn
Ventilator Induced Lung Injury
Other: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)
Other: PSV+VG (pressure support ventilation+volume guarantee)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Gazi University:

Primary Outcome Measures:
  • IL-1beta levels in tracheal aspirate material [ Time Frame: Baseline and 72 hours of mechanical ventilation ] [ Designated as safety issue: No ]
    Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

  • IL-6 level in tracheal aspirate [ Time Frame: Baseline and 72 hours of mechanical ventilation ] [ Designated as safety issue: No ]
    Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported

  • IL-8 in tracheal aspirate material [ Time Frame: Baseline and 72 hours of mechanical ventilation ] [ Designated as safety issue: No ]
    Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

  • IL-10 level in tracheal aspirate material [ Time Frame: Baseline and 72 hours of mechanical ventilation ] [ Designated as safety issue: No ]
    Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

  • TNF alfa in tracheal aspirate material [ Time Frame: Baseline and 72 hours of mechanical ventilation ] [ Designated as safety issue: No ]
    Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

  • tidal volume variability [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    variability in tidal volume measured with babyview program

  • peak inspiratory pressure variability [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    variability in peak inspiratory pressure measured with babyview program

  • respiratory rate variability [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    changes in respiratory rate, tacypnea rate

  • oxygen saturation variability [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    changes in oxygen saturation, desaturation rate, hyperoxy rate

  • lowest carbondioxide level (mmHg) [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    ratio of hypocarbic blood gases and least pCo2 level

  • highest carbondioxide level (mmHg) [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    ratio of hypercarbic blood gases and highest pCo2 level

  • lowest oxygen level (mmHg) [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    ratio of hypoxic blood gases and least pO2 level

  • highest oxygen level (mmHg) [ Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier ] [ Designated as safety issue: Yes ]
    ratio of hyperoxic blood gases and highest pO2 level


Secondary Outcome Measures:
  • bronchopulmonary dysplasia [ Time Frame: 36 weeks corrected age ] [ Designated as safety issue: Yes ]
    Oxygen requirement at 36 weeks corrected age

  • patent ductus arteriosus [ Time Frame: in the first week of post natal life of the patient ] [ Designated as safety issue: No ]
    Presence of hemodynamically significant patent ductus arteriosus in the first 7 days of life

  • necrotizing enterocolitis [ Time Frame: 36 weeks corrected age ] [ Designated as safety issue: No ]
    Necrotising entercolitis defined by clinical and radiological findings

  • intraventricular hemorrhage [ Time Frame: during first week ] [ Designated as safety issue: Yes ]
    Intraventricular hemorrhage diagnosed by head ultrasound

  • pneumothorax [ Time Frame: during first 3 days ] [ Designated as safety issue: Yes ]
    Air leak diagnosed by chest x-ray

  • pulmonary interstitial emphysema [ Time Frame: during first week ] [ Designated as safety issue: Yes ]
    Air leak diagnosed by x-ray

  • pulmonary hemorrhage [ Time Frame: during first week ] [ Designated as safety issue: Yes ]
  • retinopathy of prematurity [ Time Frame: until 36 weeks corrected age ] [ Designated as safety issue: No ]
    Retinal disease diagnosed by indirect opthtalmoscopic exam


Enrollment: 40
Study Start Date: January 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SIMV + VG mode of ventilation

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514331

Locations
Turkey
Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine
Besevler, Ankara, Turkey, 06500
Sponsors and Collaborators
Gazi University
Investigators
Principal Investigator: Ebru N Ergenekon, MD Gazi University, Division of newborn Medicine
  More Information

No publications provided

Responsible Party: Ebru Ergenekon, Prof.Dr, Gazi University
ClinicalTrials.gov Identifier: NCT01514331     History of Changes
Other Study ID Numbers: 01/2011-68
Study First Received: December 20, 2011
Last Updated: November 19, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Gazi University:
Ventilator Induced Lung Injury
Neonatal respiratory distress
Mechanical ventilation

Additional relevant MeSH terms:
Lung Injury
Wounds and Injuries
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on August 20, 2014