Bronchospasm Associated With High Nitric Oxide

Asthma Clinical Trial

Official title:

Higher Exhaled Nitric Oxide (NO) is Associated With Intraoperative Bronchospasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666510
• Other study ID #: CAP125-01
• Status: Completed
• Phase: N/A
• First received: April 23, 2008
• Last updated: April 23, 2008
• Start date: January 1999
• Est. completion date: December 2004

Study information

• Verified date: April 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with no systemic disease and registered bronchospasm during anesthesia induction

Exclusion Criteria:

• hypertension, COPD, diabetes, pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Airway Hyperresponsiveness
• Asthma
• Bronchial Spasm
• Respiratory Hypersensitivity

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled nitric oxide in parts per billion		one to six months after surgery	No
Secondary	Eosinophils concentration within sputum sample, pulmonary function tests		one to six months after surgery	No