Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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 |
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| Contact: Ebru N Ergenekon, MD | 90 532 4160676 | ebru_ergenekon@hotmail.com |
| Contact: Sezin Unal, MD | 90 532 4008018 | sezinunal@gmail.com |
| Turkey | |
| Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine | Recruiting |
| Besevler, Ankara, Turkey, 06500 | |
| Contact: Ebru N Ergenekon, MD 90 532 4160676 ebru_ergenekon@hotmail.com | |
| Contact: Sezin Ünal, MD 90 532 4008018 sezinunal@gmail.com | |
| Principal Investigator: Ebru N Ergenekon, MD | |
| Sub-Investigator: Sezin Unal, MD | |
| 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: | January 28, 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 Ventilator-Induced Lung Injury Lung Diseases |
Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013