MedTrace Logo

Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment

NCT00420069 · Status: WITHDRAWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2008-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Blood Gas Monitoring, Transcutaneous

Interventions

DEVICE

MRTX device

device for ventilation

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Diana Ram, DMD · Hadassah Medical Organization

  • David Gozal, MD · Hadassah Medical Organization

  • Ilan Gur, MD · Bikur Holim Hospital

Eligibility

Min Age
12 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Completion
2009-12-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00420069 on ClinicalTrials.gov