NCT01891942

Brief Summary

The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold for healthy subjects and COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
Last Updated

July 3, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

June 26, 2013

Last Update Submit

July 2, 2013

Conditions

Keywords

Normalsubjects

Outcome Measures

Primary Outcomes (1)

  • Twitch mouth pressure

    2 weeks

Secondary Outcomes (1)

  • Twitch oesophageal pressure

    2 weeks

Study Arms (2)

COPD patients

EXPERIMENTAL

All of the COPD patients included in this study were stable with no episodes of exacerbation within the previous 2 months. Patients with COPD were not currently being treated with oral corticosteroids.

Procedure: twitch by magstim

normal subjects

EXPERIMENTAL

Fifteen healthy men with normal lung function

Procedure: twitch by magstim

Interventions

COPD patientsnormal subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of COPD
  • Stable with no episodes of exacerbation within the previous 2 months
  • Do not currently being treated with oral corticosteroids

You may not qualify if:

  • Not stable within the previous 2 months.
  • Patients with COPD were currently being treated with oral corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute Respiratory Disease

Guangzhou, Guangdong, 510120, China

Location

Related Publications (2)

  • Walker DJ, Ertl T, Walterspacher S, Schlager D, Roecker K, Windisch W, Kabitz HJ. Respiratory muscle function during a six-week period of normocapnic hyperpnoea training. Respir Physiol Neurobiol. 2013 Aug 15;188(2):208-13. doi: 10.1016/j.resp.2013.05.005. Epub 2013 May 17.

  • Hua DM, Liang YH, Xie YK, Liu Q, Zheng ZG, Chen RC, Zhong NS. Use of twitch mouth pressure to assess diaphragm strength in patients with chronic obstructive pulmonary disease. Respir Physiol Neurobiol. 2013 Jul 1;187(3):211-6. doi: 10.1016/j.resp.2013.04.012. Epub 2013 Apr 15.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rong-chang Chen, Master

    Guangzhou Instiute of Respiratory Disease

    STUDY CHAIR
  • Dong-ming Hua, Master

    Guangzhou Institue of Respiratory Disease

    PRINCIPAL INVESTIGATOR
  • Nan-shan Zhong, Bachelor

    Guangzhou Institue of Respiratory Disease

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Influence of Trigger Threshold on Controlled Twitch Mouth Pressure

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 3, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 3, 2013

Record last verified: 2013-06

Locations