NCT00420069|Withdrawn
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Sponsor study identifier
observational
20
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The MRTX portable lightweight respirator (MRTX) provides noninvasive respiratory support using biphasic extrathoracic ventilation via a cuirass fitted around the patient's chest.The aim of the study is to evaluate the efficacy of the MRTX during dental treatment under deep sedation in comparison with the conventional treatment where children are only under monitor and only intervention is done when required.Twenty healthy children (ASA1) will wear the cuirass. PO2 saturation and ETCO2 will be recorded as a baseline. Half of the children will be ventilated (with similar values to those of physiologic respiration) and the other half will notThe study is blind, since the anesthesiologist and the dentist would not know if the cuirass of the child is connected to the MRTX or not: Group 1- 10 children with the cuirass will be connected to the MRTX and artificially ventilated at pressures of (-12/+5) at a rate of 20 per minute, and PO2 and ETCO2 will be recorded every 5 minutes. Group 2- 10 children with the cuirass will not be connected to the MRTX, but the machine will work at the same condition. Same records of PO2 and ETCO2 will be registered.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2007
Actual (reported)January 9, 2007
Actual (reported)July 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
scores of vital signs with capnograph and pulse oximeter will be recorded at baseline and every five minutes
one session
device for ventilation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah Medical Organization
Jerusalem, Jerusalem, 91120, Israel
Diana Ram, DMD
Hadassah Medical Organization
David Gozal, MD
Hadassah Medical Organization
Ilan Gur, MD
Bikur Holim Hospital
First Submitted
January 7, 2007
First Posted
January 9, 2007
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Last Updated
May 20, 2008
Record last verified: 2007-01
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Source: ClinicalTrials.gov.
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