Bronchospasm Associated With High Nitric Oxide

April 23, 2008 updated by: University of Sao Paulo

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

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05430 010
        • Hospital das Clínicas da FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital, late post-anesthesia cared patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • hypertension, COPD, diabetes, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exhaled nitric oxide in parts per billion
Time Frame: one to six months after surgery
one to six months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Eosinophils concentration within sputum sample, pulmonary function tests
Time Frame: one to six months after surgery
one to six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Joaquim E Vieira, MD, PhD, University of Sao Paulo Medical School - FMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 25, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP125-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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