Hypoxemia Clinical Trial
Official title:
A Randomised Control Trial to Determine Whether Intervention Based on a Microstream Capnography-based Ventilation Monitoring System Will Decrease Hypoxaemaia During Intravenous Sedation With Midazolam.
Verified date | May 2015 |
Source | University College Cork |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Research Ethics Committee |
Study type | Interventional |
Dentists use sedation to help patients accept difficult procedures and to relieve anxiety. During sedation, the well-being of the patient is monitored by the dental team. When carried out according to recognised guidelines,intravenous dental sedation is considered to be very safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen status) is the current gold standard in dental sedation. The main risk to the patient during sedation is a slowing of breathing due to the effects of the sedative drug. Studies from other settings where sedation is practiced suggest that an additional monitor with capnography facilitates early detection of depressed breathing. However, the results of studies from other medical settings cannot be generalised to dental sedation, because of different techniques used and the types of patients. The depth of sedation may also be vary. For dental sedation, patients remain responsive at all times and breathe for themselves. Capnography gives breath by breath information using a simple device placed close to the nose and mouth. It has been recommended by several governing medical bodies that each area of medicine, should develop its own guidelines for sedation. Therefore, there is a need to research the application of capnography for dental sedation. The proposed study will take place at a university hospital site. Patients will be randomly divided into two groups. Both groups will receive sedation in the normal way. The study group will have capnography monitoring added. The study will look for differences in breathing between the two groups. Additional information regarding other aspects of monitoring will also be obtained. The results from the proposed study may help to improve patient safety and change current practice during sedation for dentistry.
Status | Completed |
Enrollment | 190 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 14 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. American Society of Anaesthesiologists (ASA) class 1 & 2 only 2. Age 14years to 65 years 3. Ability to give written informed consent Exclusion Criteria: 1. Inability to give informed consent 2. Body Mass Index > 35 Kg/M2 3. Procedure in the upper anterior region of the mouth which prevents placement of the oral - nasal sampling device |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Ireland | University College Cork | Cork | County Cork |
Lead Sponsor | Collaborator |
---|---|
University College Cork | Medtronic - MITG |
Ireland,
Beitz A, Riphaus A, Meining A, Kronshage T, Geist C, Wagenpfeil S, Weber A, Jung A, Bajbouj M, Pox C, Schneider G, Schmid RM, Wehrmann T, von Delius S. Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: a randomized, controlled study (ColoCap Study). Am J Gastroenterol. 2012 Aug;107(8):1205-12. doi: 10.1038/ajg.2012.136. Epub 2012 May 29. — View Citation
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Deitch K, Miner J, Chudnofsky CR, Dominici P, Latta D. Does end tidal CO2 monitoring during emergency department procedural sedation and analgesia with propofol decrease the incidence of hypoxic events? A randomized, controlled trial. Ann Emerg Med. 2010 Mar;55(3):258-64. doi: 10.1016/j.annemergmed.2009.07.030. Epub 2009 Sep 24. — View Citation
Hart LS, Berns SD, Houck CS, Boenning DA. The value of end-tidal CO2 monitoring when comparing three methods of conscious sedation for children undergoing painful procedures in the emergency department. Pediatr Emerg Care. 1997 Jun;13(3):189-93. — View Citation
implementing and ensuring safe sedation practice for healthcare procedures in adults. report of an intercollegiate working party chaired by the royal college of anaesthetists. uk academy of medical royal colleges and their faculties (2001).
Miner JR, Heegaard W, Plummer D. End-tidal carbon dioxide monitoring during procedural sedation. Acad Emerg Med. 2002 Apr;9(4):275-80. — View Citation
Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. — View Citation
Sivilotti ML, Messenger DW, van Vlymen J, Dungey PE, Murray HE. A comparative evaluation of capnometry versus pulse oximetry during procedural sedation and analgesia on room air. CJEM. 2010 Sep;12(5):397-404. — View Citation
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Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arterial oxygen desaturation (SpO2 < 95%) | This primary outcome measure was chosen in part because it represents a threshold point for sedation staff to stimulate patients to breathe via tactile or verbal actions. | "participants will be followed for the duration of their sedation appointment, an expected average of one hour" | Yes |
Secondary | Degree of hypoxemia | Degree of hypoxemia; Normal (95% and above) Mild (93% to 94.99%), Moderate (90% to 92.99%) Severe hypoxemia (< 90%) | "participants will be followed for the duration of their sedation appointment, an expected average of one hour | Yes |
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