A new integrative weaning index of discontinuation from mechanical ventilation

ISRCTN	ISRCTN92117906
DOI	https://doi.org/10.1186/ISRCTN92117906
Secondary identifying numbers	N/A

Submission date: 02/02/2009
Registration date: 10/02/2009
Last edited: 29/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Sergio Nemer
Scientific

Hospital de Clínicas de Niterói
Rua La Sale, 12
Centro, Niterói
Rio De Janeiro
24020-090
Brazil

Email	snnemer@urbi.com.br

Study information

Study design	Observational cohort blinded (physician) trial
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A new integrative weaning index of discontinuation from mechanical ventilation: an observational study
Study hypothesis	A new integrative weaning index can predict the weaning outcome better than traditional indexes.
Ethics approval(s)	Ethics Committees of Hospital de Clínicas de Niterói approved in August 2004 (ref: USP/FM/SBD-033/07)
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
Primary outcome measure	Better accuracy in predicting weaning outcome
Secondary outcome measures	Adequate prognosis
Overall study start date	01/09/2004
Overall study end date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	331
Participant inclusion criteria	Patients (both males and females) more than 24 hours in mechanical ventilation in weaning process.
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

Study participating centre

Hospital de Clínicas de Niterói

Rio De Janeiro
24020-090
Brazil

Sponsor information

Niterói Hospital (Hospital de Clínicas de Niterói) (Brazil)
Hospital/treatment centre

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

Email	pcsouza@pobox.com
Website	http://www.hcniteroi.com.br

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2009		Yes	No