NCT02987036

Brief Summary

The purpose of this study is to find out weather differences in administration nebulizer technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables (Compliance, resistance and PEEPi) during controlled mechanical ventilation.

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 Jan 2015

Typical duration for not_applicable

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

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

January 13, 2016

Last Update Submit

December 5, 2016

Conditions

Respiratory Failure

Keywords

nebulizer technologies, lung mechanics, beta-agonistic drug

Outcome Measures

Primary Outcomes (1)

  • change of intrinsi PPPE

    0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration

Secondary Outcomes (2)

  • change of respioratory resistance

    0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration

  • change of respiratory system Compliance

    0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration

Study Arms (2)

Aerogen

EXPERIMENTAL

Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Aerogen

Device: Aerogen

Jet Nebulizer

OTHER

Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet Nebulizer

Device: Jet nebulizer

Interventions

AerogenDEVICE

Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by mesh nebulizer

Aerogen
Jet nebulizerDEVICE

Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet nebulizer

Jet Nebulizer

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on mechanical ventilation for more than 48 hours
  • PEEPi ≥3 cm H2O and expected to remain on controlled mechanical ventilation for at least 24 hours.

You may not qualify if:

  • Severe chronic lung disease with chronic hypercapnia (PCO2\>45 mm Hg), Chronic hypoxemia (PO2\< 55mm Hg with FiO2=0,21), hospitalization within last 6 months for respiratory failure (PCO2\>50; PO2\<55mm Hg), Secondary polycythemia, severe pulmonary hypertension (mPAP \>40 mm Hg.
  • Unable to obtain consent
  • Acute myocardial infarction
  • Severe congestive heart failure
  • Heart rate greater than maximal predicted heart rate MHR85 (MHR 85=0.85 x (220-age).
  • Burns over more than 40% of body surface area
  • Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  • Allogenic bone marrow transplantation within 5 years prior to the study
  • Diffuse alveolar hemorrhage from vaculitis
  • Morbid obesity
  • Moribund, not expected to survive 24 hours
  • Daily use of beta agonists prior to hospitalization
  • Participation in other study
  • Chronic liver disease
  • Neuromuscular disease that impairs ability to breath without assistance (e.g. Cervical spine cord injury at level C5 and higher, Amyotrophic lateral sclerosis, Guillain-Barre syndrome or myasthenia gravis)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Ling Ling, Dr

    Zhongda Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 13, 2016

First Posted

December 8, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)