NCT01565226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.5 years

First QC Date

March 25, 2012

Last Update Submit

November 1, 2016

Conditions

Intubated Neonates That Require High Frequency Ventilation

Keywords

CapnographyCO2neonatesHigh Frequency ventilation (HFV)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Open

open, observational study

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neonates

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Soroka MC

Beersheba, Israel

Location

Bnai Zion MC

Haifa, Israel

Location

Shaare Zedek MC

Jerusalem, Israel

Location

Study Officials

  • Amir Kugelman, Prof.

    Bnai Zion MC, Haifa Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2012

First Posted

March 28, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

IL(3)