Capnography in Neonates Ventilated With High Frequency Ve... | NCT01565226

Studies
Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study

NCT01565226

Sponsor

Oridion

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Intubated Neonates That Require High Frequency Ventilation

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Mar 25, 2012

First Submission Date that Met QC Criteria

Mar 27, 2012

First Posted Date

Mar 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This will be an observational study. Respiratory data will be recorded using Capnostream20p. There will be no use in the recorded data for the medical care of the patients. Other clinical data will be captured in the CRF. Similar study is currently conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited without any adverse events.
During the study the medical team will capture in the CRF the following: Blood gas and distal capnography values at time of sampling, ventilator settings at time of sampling.
Changes made in the ventilation parameters, blood gas time and results, concomitant treatment (e.g. suction) and concomitant medication (respiratory related e.g. surfactant), vital signs all these will be retrieved from the patient's medical charts.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
Open		open, observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the feasibility of measuring distal capnography on HFV and to assess its correlation and agreement with PaCO2 in infants ventilated with HFV in a prospective study.		August 2012 - February 2015

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico)
Neonates that their respiratory condition requires HFV
Neonates expected to have at least 3 pairs of distal capnography measurements and blood gas samplings.

Exclusion Criteria:

Intubated neonates with single-lumen ETTs
Neonates who are ventilated with conventional ventilation
Any significant medical condition which, at the investigator's discretion, may interfere with the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Neonates

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Kugelman, Prof.	Bnai Zion MC, Haifa Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka MC		Beersheba			Israel
Bnai Zion MC