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

Ventilator Induced Lung Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514331
• Other study ID #: 01/2011-68
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: November 19, 2013
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Injury
• Respiratory Distress, Newborn
• Ventilator Induced Lung Injury
• Ventilator-Induced Lung Injury

Intervention

Other:
• SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)
Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode
• PSV+VG (pressure support ventilation+volume guarantee)
Neonates who need mechanical ventilation will be ventilated with PSV+VG

Locations

Country	Name	City	State
Turkey	Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine	Besevler	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	tidal volume variability	variability in tidal volume measured with babyview program	72 hours of mechanical ventilation or entire ventilation time if extubated earlier	Yes
Primary	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	Yes
Primary	respiratory rate variability	changes in respiratory rate, tacypnea rate	72 hours of mechanical ventilation or entire ventilation time if extubated earlier	Yes
Primary	oxygen saturation variability	changes in oxygen saturation, desaturation rate, hyperoxy rate	72 hours of mechanical ventilation or entire ventilation time if extubated earlier	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	bronchopulmonary dysplasia	Oxygen requirement at 36 weeks corrected age	36 weeks corrected age	Yes
Secondary	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	No
Secondary	necrotizing enterocolitis	Necrotising entercolitis defined by clinical and radiological findings	36 weeks corrected age	No
Secondary	intraventricular hemorrhage	Intraventricular hemorrhage diagnosed by head ultrasound	during first week	Yes
Secondary	pneumothorax	Air leak diagnosed by chest x-ray	during first 3 days	Yes
Secondary	pulmonary interstitial emphysema	Air leak diagnosed by x-ray	during first week	Yes
Secondary	pulmonary hemorrhage		during first week	Yes
Secondary	retinopathy of prematurity	Retinal disease diagnosed by indirect opthtalmoscopic exam	until 36 weeks corrected age	No