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

November 19, 2013 updated by: Ebru Ergenekon, Gazi University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Besevler, Ankara, Turkey, 06500
        • Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • SIMV + VG mode of ventilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 72 hours of mechanical ventilation
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
Baseline and 72 hours of mechanical ventilation
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
Baseline and 72 hours of mechanical ventilation
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
Baseline and 72 hours of mechanical ventilation
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
Baseline and 72 hours of mechanical ventilation
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
respiratory rate variability
Time Frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
changes in respiratory rate, tacypnea rate
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier
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
72 hours of mechanical ventilation or entire ventilation time if extubated earlier

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
bronchopulmonary dysplasia
Time Frame: 36 weeks corrected age
Oxygen requirement at 36 weeks corrected age
36 weeks corrected age
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
in the first week of post natal life of the patient
necrotizing enterocolitis
Time Frame: 36 weeks corrected age
Necrotising entercolitis defined by clinical and radiological findings
36 weeks corrected age
intraventricular hemorrhage
Time Frame: during first week
Intraventricular hemorrhage diagnosed by head ultrasound
during first week
pneumothorax
Time Frame: during first 3 days
Air leak diagnosed by chest x-ray
during first 3 days
pulmonary interstitial emphysema
Time Frame: during first week
Air leak diagnosed by x-ray
during first week
pulmonary hemorrhage
Time Frame: during first week
during first week
retinopathy of prematurity
Time Frame: until 36 weeks corrected age
Retinal disease diagnosed by indirect opthtalmoscopic exam
until 36 weeks corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebru N Ergenekon, MD, Gazi University, Division of newborn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01/2011-68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventilator Induced Lung Injury

Clinical Trials on PSV+VG (pressure support ventilation+volume guarantee)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings