NCT00666510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
Last Updated

April 25, 2008

Status Verified

April 1, 2008

First QC Date

April 23, 2008

Last Update Submit

April 23, 2008

Conditions

AsthmaAirway Hyperresponsiveness

Keywords

nitric oxidebronchospasmanesthesiainduced sputumasthma

Outcome Measures

Primary Outcomes (1)

  • Exhaled nitric oxide in parts per billion

    one to six months after surgery

Secondary Outcomes (1)

  • Eosinophils concentration within sputum sample, pulmonary function tests

    one to six months after surgery

Study Arms (3)

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

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital, late post-anesthesia cared patients

You may qualify if:

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

You may not qualify if:

  • hypertension, COPD, diabetes, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05430 010, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

AsthmaRespiratory HypersensitivityBronchial Spasm

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Joaquim E Vieira, MD, PhD

    University of Sao Paulo Medical School - FMUSP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

January 1, 1999

Study Completion

December 1, 2004

Last Updated

April 25, 2008

Record last verified: 2008-04

Locations

BR(1)