Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants? (N_SIMV)

June 26, 2013 updated by: Prof. Dr. Helmut Hummler

The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).

Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.

Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Wüttemberg
      • Ulm, Baden-Wüttemberg, Germany, 89075
        • Recruiting
        • Children's Hospital University of Ulm
        • Principal Investigator:
          • Helmut Hummler, Prof. Dr

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.

  • Gestational age <32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
  • Informed consent available.

Exclusion Criteria:

• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-nIMV
nIMV synchronized using abdominal pressure capsule sensor device
Device: S-nIMV
Synchronization of nasal breaths to infant's own respiratory effort
Placebo Comparator: nIMV
non-synchronized nasal intermittent mandatory ventilation group
Device: S-nIMV
Synchronization of nasal breaths to infant's own respiratory effort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
phasic esophageal pressure deflection
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Cerebral oxygen saturation
Time Frame: 4 hours
4 hours
Arterial oxygen saturation
Time Frame: 4 hours
4 hours

Collaborators and Investigators

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

Sponsor

Prof. Dr. Helmut Hummler

Investigators

  • Principal Investigator: Hummler Helmut, Prof. Dr, University of Ulm

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

July 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULMN_SIMV

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.

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