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

NCT ID: NCT01565226

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

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* 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

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Conditions

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Intubated Neonates That Require High Frequency Ventilation

Keywords

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Capnography CO2 neonates High Frequency ventilation (HFV)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Open

open, observational study

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oridion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amir Kugelman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion MC, Haifa Israel

Locations

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Soroka MC

Beersheba, , Israel

Site Status

Bnai Zion MC

Haifa, , Israel

Site Status

Shaare Zedek MC

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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D007171

Identifier Type: -

Identifier Source: org_study_id