Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 7, 2007 | ||||||||||||
| Last Updated Date | May 19, 2008 | ||||||||||||
| Start Date ICMJE | July 2008 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
scores of vital signs with capnograph and pulse oximeter will be recorded at baseline and every five minutes [ Time Frame: one session ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
scores of vital signs with capnograph and pulse oximeter will be recorded at baseline and every five minutes | ||||||||||||
| Change History | Complete list of historical versions of study NCT00420069 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment | ||||||||||||
| Official Title ICMJE | Biphasic Extrathoracic Cuirass Ventilation During Dental Treatment Under Deep Sedation | ||||||||||||
| 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Not Provided | ||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Not Provided | ||||||||||||
| Study Population | Not Provided | ||||||||||||
| Condition ICMJE | Blood Gas Monitoring, Transcutaneous | ||||||||||||
| Intervention ICMJE | Device: MRTX device
device for ventilation |
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| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||||||
| Estimated Completion Date | December 2009 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 12 Months to 6 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00420069 | ||||||||||||
| Other Study ID Numbers ICMJE | di123HMO-CTIL | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||||||
| Verification Date | January 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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