AsthmaNCT00666510
Bronchospasm Associated With High Nitric Oxide
An observational study of Asthma and Airway Hyperresponsiveness, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Airway Hyperresponsiveness
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 1999to Dec 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hospital, late post-anesthesia cared patients
Who may be able to join
- patients with no systemic disease and registered bronchospasm during anesthesia induction
Who cannot join
- hypertension, COPD, diabetes, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma, Airway Hyperresponsiveness
- Keywords
- nitric oxide, bronchospasm, anesthesia, induced sputum, asthma
- Medical subject headings
- Asthma, Respiratory Hypersensitivity, Bronchial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Exhaled nitric oxide in parts per billion
Measured: one to six months after surgery
Secondary outcomes (1)
Eosinophils concentration within sputum sample, pulmonary function tests
Measured: one to six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJan 1999
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Joaquim E Vieira, MD, PhD, Principal investigator, University of Sao Paulo Medical School - FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666510
- Sponsor's protocol ID
- CAP125-01
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Exhaled Nitric Oxide (NO) is Associated With Intraoperative Bronchospasm
- ClinicalTrials.gov ID
- NCT00666510
- Acronym / sponsor ID
- CAP125-01
- Conditions
- Asthma, Airway Hyperresponsiveness
- Keywords
- nitric oxide, bronchospasm, anesthesia, induced sputum, asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Dec 2004 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital, late post-anesthesia cared patients
Key inclusion criteria (1 listed)
- patients with no systemic disease and registered bronchospasm during anesthesia induction
Key exclusion criteria (1 listed)
- hypertension, COPD, diabetes, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exhaled nitric oxide in parts per billion
Time frame: one to six months after surgery
1 secondary outcome
Eosinophils concentration within sputum sample, pulmonary function tests
Time frame: one to six months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquim E Vieira, MD, PhD principal investigator
University of Sao Paulo Medical School - FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Airway Hyperresponsiveness, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled nitric oxide in parts per billion (time frame: one to six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2008.