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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00859209
Other study ID # 68/08
Secondary ID
Status Completed
Phase N/A
First received February 10, 2009
Last updated August 11, 2015
Start date December 2008
Est. completion date April 2015

Study information

Verified date March 2009
Source Bnai Zion Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of HealthUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2).


Description:

All infants with double lumen ETT on HFV are eligible.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Months
Eligibility Inclusion Criteria:

- All intubated infants with double lumen ETT ventilated with HFV

Exclusion Criteria:

- Infants ventilated with single lumen ETT

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Infants in NICU Ventilated With HFV

Locations

Country Name City State
Israel Bnai Zion Medical Center Haifa

Sponsors (2)

Lead Sponsor Collaborator
Bnai Zion Medical Center Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The investigators primary outcome measure will be to evaluate the accuracy and the correlation of Microstream® dEtCO2 with the gold standard of PaCO2. A Year No