NCT02218398

Brief Summary

Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2013

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

February 6, 2014

Last Update Submit

August 15, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

airway resistancelung complianceDuration of mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Percentage of 12% Decrease in airway resistance

    30 minutes

Secondary Outcomes (1)

  • Duration of mechanical ventilation

    participants will be followed for the duration of ICU stay, an expected average of 28 days

Study Arms (2)

Bronchodilator

EXPERIMENTAL

Albuterol 3-4 times per day, steroids when necessary.

Drug: Albuterol

No drug

NO INTERVENTION

No drug

Interventions

AlbuterolDRUG
Bronchodilator

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • should meet all the criteria:
  • Acute exacerbated chronic obstructive pulmonary disease
  • Invasive mechanical ventilation with intubation outside ICU no more than 48 hours

You may not qualify if:

  • Meet any of the criteria:
  • Asthma
  • Tracheotomy
  • Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days)
  • Unstable hemodynamic status
  • Severe pneumonia
  • Contraindication for bronchodilator
  • Contraindication for sedation
  • Refusal to participate in study
  • Re-intubation in 48 hours
  • Mental disorder, could not understand and accomplish pulmonary function test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Intensive Care Unit, Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 101100, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Central Study Contacts

Jie Li, Master

CONTACT

86-13552976483lijie8497@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RRT-NPS

Study Record Dates

First Submitted

February 6, 2014

First Posted

August 18, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

CN(1)