Condition category
Respiratory
Date applied
02/02/2009
Date assigned
10/02/2009
Last edited
29/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sergio Nemer

ORCID ID

Contact details

Hospital de Clínicas de Niterói
Rua La Sale
12
Centro
Niterói
Rio De Janeiro
24020-090
Brazil
snnemer@urbi.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A new integrative weaning index of discontinuation from mechanical ventilation: an observational study

Acronym

Study hypothesis

A new integrative weaning index can predict the weaning outcome better than traditional indexes.

Ethics approval

Ethics Committees of Hospital de Clínicas de Niterói approved in August 2004 (ref: USP/FM/SBD-033/07)

Study design

Observational cohort blinded (physician) trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mechanical ventilation weaning

Intervention

Patients were classified as weaned or not weaned according to the ability to sustain spontaneous breathing for more than 48 hours post-extubation. Continuous positive airway pressure (CPAP) of 5 cm H2O was provided to avoid reconnection to the ventilator where necessary. Patients that remained in non invasive ventilation (NIV) were considered as 'weaning in progress' and could not be classified as weaned or not weaned. Patients that presented with post-extubation respiratory failure received all care to avoid reintubation but were ventilated by NIV where necessary.

The indexes were measured by the respiratory physiotherapists before the spontaneous breathing trials (SBTs). The decision to return to mechanical ventilation was made by the physician in charge (who was completely blind about the results of the indexes evaluated), based on the signs of poor tolerance.

The following measurements were taken for each weaning index:
1. Rapid shallow breathing index (f/Vt ratio)
2. Quasi-static compliance of the respiratory system (Cqst,rs)
3. Tidal volume
4. Respiratory rate
5. PaO2/FiO2 ratio
6. Volume minute
7. Airway occlusion pressure (P 0.1)
8. Integrative weaning index (Cqst,rs x arterial oxygen saturation / f/Vt ratio). This is a newly proposed index, used in some hospitals in Brazil.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Better accuracy in predicting weaning outcome

Secondary outcome measures

Adequate prognosis

Overall trial start date

01/09/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (both males and females) more than 24 hours in mechanical ventilation in weaning process.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

331

Participant exclusion criteria

1. Patients younger than 18 years old
2. Neurological and neuromuscular diseases
3. Patients who have been tracheostomised

Recruitment start date

01/09/2004

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Brazil

Trial participating centre

Hospital de Clínicas de Niterói
Rio De Janeiro
24020-090
Brazil

Sponsor information

Organisation

Niterói Hospital (Hospital de Clínicas de Niterói) (Brazil)

Sponsor details

c/o Dr. Paulo Cesar Pereira de Souza
Rua La Sale
12
Centro
Niterói
Rio de Janeiro
24020-090
Brazil
pcsouza@pobox.com

Sponsor type

Hospital/treatment centre

Website

http://www.hcniteroi.com.br

Funders

Funder type

Hospital/treatment centre

Funder name

Niterói Hospital (Hospital de Clínicas de Niterói) (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19772625

Publication citations

  1. Results

    Nemer SN, Barbas CS, Caldeira JB, Cárias TC, Santos RG, Almeida LC, Azeredo LM, Noé RA, Guimarães BS, Souza PC, A new integrative weaning index of discontinuation from mechanical ventilation., Crit Care, 2009, 13, 5, R152, doi: 10.1186/cc8051.

Additional files

Editorial Notes