Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005382
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Sources of Variability in Peak Expiratory Flow
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To provide information necessary for the development of standards for peak expiratory flow PEF test performance in populations studies
Detailed Description:
BACKGROUND
While PEF has routinely been applied in the diagnosis and management of asthma scientists were finding new applications for PEF as both a clinical and epidemiologic tool for following individuals with pulmonary diseases studying the natural history of chronic obstructive pulmonary disease and evaluating the impact of environmental exposures on lung function Yet the standardization of the PEF measurement lagged behind its application
The little attention paid to the performance characteristics of the PEF maneuver contrasted sharply with the efforts to standardize measurement procedures for FEV1 and FVC The American Thoracic Society devoted a great deal of attention to studying these measures and published guidelines for the standardization of their measurement These guidelines included detailed protocols for calibrating equipment administering the tests determining reproducibility and interpreting results
The research provided data on the optimal number of trials per test session the difference between a PEF performed during a full forced expiratory effort and that resulting from a short blast the impact of test supervision on test performance and the reproducibility of the PEF measurement
DESIGN NARRATIVE
A baseline survey of ventilatory function was performed using spirometry PEF was measured daily with a mini-Wright Peak Flow Meter over a period of several weeks in a study of 201 normals staff faculty and graduate students at the University of Massachusetts Lowell Serial PEF data were collected on a group of mild asthmatics identified in a local occupational medicine clinic Finally performance characteristics were examined in serial PEF data from two existing occupational cohort studies
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
While PEF has routinely been applied in the diagnosis and management of asthma scientists were finding new applications for PEF as both a clinical and epidemiologic tool for following individuals with pulmonary diseases studying the natural history of chronic obstructive pulmonary disease and evaluating the impact of environmental exposures on lung function Yet the standardization of the PEF measurement lagged behind its application
The little attention paid to the performance characteristics of the PEF maneuver contrasted sharply with the efforts to standardize measurement procedures for FEV1 and FVC The American Thoracic Society devoted a great deal of attention to studying these measures and published guidelines for the standardization of their measurement These guidelines included detailed protocols for calibrating equipment administering the tests determining reproducibility and interpreting results
The research provided data on the optimal number of trials per test session the difference between a PEF performed during a full forced expiratory effort and that resulting from a short blast the impact of test supervision on test performance and the reproducibility of the PEF measurement
DESIGN NARRATIVE
A baseline survey of ventilatory function was performed using spirometry PEF was measured daily with a mini-Wright Peak Flow Meter over a period of several weeks in a study of 201 normals staff faculty and graduate students at the University of Massachusetts Lowell Serial PEF data were collected on a group of mild asthmatics identified in a local occupational medicine clinic Finally performance characteristics were examined in serial PEF data from two existing occupational cohort studies
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL051975 | NIH | None | httpsreporternihgovquickSearchR01HL051975 |