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

NCT ID: NCT01514331

Last Updated: 2013-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Respiratory Distress, Newborn; Ventilator Induced Lung Injury

Keywords

Ventilator Induced Lung Injury; Neonatal respiratory distress; Mechanical ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

PSV+VG

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

Group Type: ACTIVE_COMPARATOR

PSV+VG (pressure support ventilation+volume guarantee)

Intervention Type: OTHER

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

SIMV+VG

Neonates who require mechanical ventilation and randomised to synchronised intermittant mandatory ventilation + volume guarantee (SIMV+VG) mode

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

PSV+VG (pressure support ventilation+volume guarantee)

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

Intervention Type: OTHER

Other Intervention Names

SIMV + VG mode of ventilation; PSV+ VG mode of ventilation

Eligibility 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

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Ergenekon

Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru N Ergenekon, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Division of newborn Medicine

Locations

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

Beşevler, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

01/2011-68

Identifier Type: -

Identifier Source: org_study_id