NCT00420069

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 20, 2008

Status Verified

January 1, 2007

First QC Date

January 7, 2007

Last Update Submit

May 19, 2008

Conditions

Blood Gas Monitoring, Transcutaneous

Outcome Measures

Primary Outcomes (1)

  • scores of vital signs with capnograph and pulse oximeter will be recorded at baseline and every five minutes

    one session

Interventions

MRTX deviceDEVICE

device for ventilation

Eligibility Criteria

Age12 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children (ASA1)
  • Need of dental treatment under deep sedation
  • Informed consent of parents or guardian

You may not qualify if:

  • Not healthy children (ASA 2, 3, 4, 5)
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Jerusalem, 91120, Israel

Location

Study Officials

  • Diana Ram, DMD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • David Gozal, MD

    Hadassah Medical Organization

    STUDY CHAIR

  • Ilan Gur, MD

    Bikur Holim Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2007

First Posted

January 9, 2007

Study Start

July 1, 2008

Study Completion

December 1, 2009

Last Updated

May 20, 2008

Record last verified: 2007-01

Locations

IL(1)