Back to resultsIs Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants? (N_SIMV)
Primary Purpose
Respiratory Distress Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
S-nIMV
Sponsored by
About this trial
This is an interventional health services research trial for Respiratory Distress Syndrome focused on measuring Premature Infants, snychronized ventilation, non-invasive ventilation, RDS
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital University of UlmRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S-nIMV
nIMV
Arm Description
nIMV synchronized using abdominal pressure capsule sensor device
non-synchronized nasal intermittent mandatory ventilation group
Outcomes
Primary Outcome Measures
phasic esophageal pressure deflection
Secondary Outcome Measures
Cerebral oxygen saturation
Arterial oxygen saturation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01664832
Brief Title
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Acronym
N_SIMV
Official Title
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Helmut Hummler
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Premature Infants, snychronized ventilation, non-invasive ventilation, RDS
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-nIMV
Arm Type
Experimental
Arm Description
nIMV synchronized using abdominal pressure capsule sensor device
Arm Title
nIMV
Arm Type
Placebo Comparator
Arm Description
non-synchronized nasal intermittent mandatory ventilation group
Intervention Type
Device
Intervention Name(s)
S-nIMV
Intervention Description
Synchronization of nasal breaths to infant's own respiratory effort
Primary Outcome Measure Information:
Title
phasic esophageal pressure deflection
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Cerebral oxygen saturation
Time Frame
4 hours
Title
Arterial oxygen saturation
Time Frame
4 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helmut Hummle, Prof. Dr.
Phone
0731-500-57168
Email
helmut.hummler@uniklinik-ulm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huang, Master
Phone
015776891592
Email
hhuangli@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hummler Helmut, Prof. Dr
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital University of Ulm
City
Ulm
State/Province
Baden-Wüttemberg
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helmut Hummler, Prof. Dr
12. IPD Sharing Statement
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Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
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