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Bronchospasm Associated With High Nitric Oxide

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ClinicalTrials.gov Identifier: NCT00666510
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : April 25, 2008
Sponsor:
Information provided by:
University of Sao Paulo

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.

Condition or disease
Asthma Airway Hyperresponsiveness

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.

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Higher Exhaled Nitric Oxide (NO) is Associated With Intraoperative Bronchospasm
Study Start Date : January 1999
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Bronchospasm
Patients who presented bronchospasm during anesthesia induction
Asthma
Patients who presented bronchospasm during anesthesia induction and were identified as asthmatics
Control
Patients who were submitted to anesthesia induction and showed no complications



Primary Outcome Measures :
  1. Exhaled nitric oxide in parts per billion [ Time Frame: one to six months after surgery ]

Secondary Outcome Measures :
  1. Eosinophils concentration within sputum sample, pulmonary function tests [ Time Frame: one to six months after surgery ]

Biospecimen Retention:   Samples Without DNA
Sputum


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospital, late post-anesthesia cared patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hypertension, COPD, diabetes, pregnancy

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666510


Locations
Brazil
Hospital das Clínicas da FMUSP
São Paulo, Brazil, 05430 010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Joaquim E Vieira, MD, PhD University of Sao Paulo Medical School - FMUSP

Responsible Party: Joaquim Edson Vieira, Fisiopatologia Experimental FMUSP
ClinicalTrials.gov Identifier: NCT00666510     History of Changes
Other Study ID Numbers: CAP125-01
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008

Keywords provided by University of Sao Paulo:
nitric oxide
bronchospasm
anesthesia
induced sputum
asthma

Additional relevant MeSH terms:
Bronchial Spasm
Respiratory Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents