A new integrative weaning index of discontinuation from mechanical ventilation
| ISRCTN | ISRCTN92117906 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92117906 |
| Protocol serial number | N/A |
| Sponsor | Niterói Hospital (Hospital de Clínicas de Niterói) (Brazil) |
| Funder | Niterói Hospital (Hospital de Clínicas de Niterói) (Brazil) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Sergio Nemer
Scientific
Scientific
Hospital de Clínicas de Niterói
Rua La Sale, 12
Centro, Niterói
Rio De Janeiro
24020-090
Brazil
| snnemer@urbi.com.br |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort blinded (physician) trial |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | A new integrative weaning index of discontinuation from mechanical ventilation: an observational study |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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(s) |
Better accuracy in predicting weaning outcome |
| Key secondary outcome measure(s) |
Adequate prognosis |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 331 |
| Key inclusion criteria | Patients (both males and females) more than 24 hours in mechanical ventilation in weaning process. |
| Key exclusion criteria | 1. Patients younger than 18 years old 2. Neurological and neuromuscular diseases 3. Patients who have been tracheostomised |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Hospital de Clínicas de Niterói
Rio De Janeiro
24020-090
Brazil
24020-090
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
