NCT01065428

Brief Summary

The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully extubated and those who failed weaning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

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

December 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 16, 2010

Completed
Last Updated

August 31, 2011

Status Verified

August 1, 2011

Enrollment Period

1.6 years

First QC Date

February 8, 2010

Results QC Date

October 18, 2010

Last Update Submit

August 29, 2011

Conditions

Keywords

neuromechanical efficiencyneuroventilatory efficiencyweaningRespiration, Artificial

Outcome Measures

Primary Outcomes (1)

  • Neuroventilatory Efficiency (NVE)

    NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.

    at 30 minutes of the spontaneous breathing trials (SBT)

Secondary Outcomes (1)

  • Neuromechanical Efficiency (NME)

    at 30 minutes of the spontaneous breathing trials (SBT)

Study Arms (2)

Weaning failure

Weaning failure:(1) failed SBT; (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.

Weaning successful

Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who required mechanical ventilation for more than 24 h.

You may qualify if:

  • We chose a number of eligible patients which were admitted to ICU of the Zhong-Da Hospital and required mechanical ventilation for more than 24 h.

You may not qualify if:

  • (1) age \<18 or \>85 years, (2) tracheostomy, (3) treatment abandonment, (4) history of esophageal varices, (5) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (6) coagulation disorders (INR ratio\>1.5 and APTT\>44 s), (7) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (8) history of leukemia, severe chronic liver or chronic cardiac disease, (9) solid organ transplantation, (10) malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Zhong-Da Hospital

Nanjing, Jiangsu, 21009, China

Location

Related Publications (1)

  • Liu L, Liu H, Yang Y, Huang Y, Liu S, Beck J, Slutsky AS, Sinderby C, Qiu H. Neuroventilatory efficiency and extubation readiness in critically ill patients. Crit Care. 2012 Jul 31;16(4):R143. doi: 10.1186/cc11451.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Parameters of arterial blood gases, haemodynamic and mechanics of breathing

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

Title
Dr. Haibo Qiu; Dr. Christer Sinderby
Organization
Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine, China

Study Officials

  • Haibo Qiu, MD, Phd

    Southeast University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

December 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 31, 2011

Results First Posted

November 16, 2010

Record last verified: 2011-08

Locations