Bronchospasm Associated With High Nitric Oxide | NCT00666510

Studies
Bronchospasm Associated With High Nitric Oxide

NCT00666510

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Apr 25, 2008Estimated

Enrollment

31Actual

Phase

Not provided

Conditions

Asthma
Airway Hyperresponsiveness

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Not provided

Completion Date

Dec 2004Actual

First Submitted Date

Apr 23, 2008

First Submission Date that Met QC Criteria

Apr 23, 2008

First Posted Date

Apr 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2008

Last Update Posted Date

Apr 25, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with no systemic disease and registered bronchospasm during anesthesia induction

Exclusion Criteria:

hypertension, COPD, diabetes, pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital, late post-anesthesia cared patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joaquim E Vieira, MD, PhD	University of Sao Paulo Medical School - FMUSP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Clínicas da FMUSP		São Paulo	São Paulo	05430 010	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D012130	Respiratory Hypersensitivity
D001986	Bronchial Spasm

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided