Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00420069
First received: January 7, 2007
Last updated: May 19, 2008
Last verified: January 2007

January 7, 2007
May 19, 2008
July 2008
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scores of vital signs with capnograph and pulse oximeter will be recorded at baseline and every five minutes [ Time Frame: one session ]
scores of vital signs with capnograph and pulse oximeter will be recorded at baseline and every five minutes
Complete list of historical versions of study NCT00420069 on ClinicalTrials.gov Archive Site
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Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment
Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment Under Deep Sedation

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.

The MediventRTX 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 not. The reason of the ventilation is to prevent apnea and high values of PCO2 due to superficial and not efficient breathing. An anesthesiologist is routinely present during treatment under deep sedation. After the child would be deep sedated, he/she will be connected to the cuirass that should be tightly fitted around the patient's chest. The cuirass consists of a clear, flexible plastic enclosure surrounding the chest and abdomen. Its borders are covered by a soft foam rubber, which creates an airtight seal around the patient. By choosing the appropriate cuirass size, the apparatus is capable of ventilating a wide range of different-sized subjects, from infants to the obese adult. The cuirass is connected to a computerized power unit by a wide-bore tube and the respiratory parameters are controlled by a feedback mechanism between the two. The power unit works by creating cyclic pressure changes inside the cuirass. The negative pressure (vacuum) creates chest expansion-inhalation. The positive pressure creates chest compression-exhalation. Thus, both inspiratory and expiratory phases are actively controlled, and the chest is oscillated around a variable negative baseline pressure. The system was found to be effective in a variety of clinical settings, with pressures of −25 to +15 cm H2O, inspiratory/expiratory (I/E) ratios of 1/1 to 1/3, and frequencies of 60 to 150 cpm

The 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.

Observational
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Blood Gas Monitoring, Transcutaneous
Device: MRTX device
device for ventilation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
December 2009
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Inclusion Criteria:

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

Exclusion Criteria:

  • Not healthy children (ASA 2, 3, 4, 5)
  • No informed consent
Both
12 Months to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00420069
di123HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Diana Ram, DMD Hadassah Medical Organization
Study Chair: David Gozal, MD Hadassah Medical Organization
Study Director: Ilan Gur, MD Bikur Holim Hospital
Hadassah Medical Organization
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP