Bronchospasm Associated With High Nitric Oxide
| Tracking Information | |||||
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| First Received Date ICMJE | April 23, 2008 | ||||
| Last Updated Date | April 23, 2008 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Exhaled nitric oxide in parts per billion [ Time Frame: one to six months after surgery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Eosinophils concentration within sputum sample, pulmonary function tests [ Time Frame: one to six months after surgery ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bronchospasm Associated With High Nitric Oxide | ||||
| Official Title ICMJE | Higher Exhaled Nitric Oxide (NO) is Associated With Intraoperative Bronchospasm | ||||
| Brief Summary | Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm. |
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| Detailed Description | Previous studies in asthmatic patients suggested that exhaled nitric oxide may represent a noninvasive measure for airway inflammation. Anesthesia information forms from 1999 throughout 2004 were revised (n=146.358). Bronchospasm occurrence appeared registered on 863 forms. From those, nine were identified as non-asthmatics patients (Bronchospasm group). Also, 12 asthmatics constituted one additional group (Asthma group) and 10 subjects with no previous airway disease or symptoms (Control group). All subjects were submitted to Exhaled nitric oxide measurements (parts/billion), spirometry and induced sputum. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Sputum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Hospital, late post-anesthesia cared patients |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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 | Completed | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | December 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00666510 | ||||
| Other Study ID Numbers ICMJE | CAP125-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joaquim Edson Vieira, Fisiopatologia Experimental FMUSP | ||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||
| Verification Date | April 2008 | ||||
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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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