A pilot study of a new test to predict extubation failure
| ISRCTN | ISRCTN76206152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76206152 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/08/2008
- Registration date
- 04/12/2008
- Last edited
- 21/09/2009
- 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 Felipe J Solsona
Scientific
Scientific
Hospital del Mar
Institut Municipal d'Assistència Sanitària (IMAS)
Passeig Maritim 25-29
Barcelona
08003
Spain
Study information
| Study design | Prospective non-randomised pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | We hypothesise that it is possible to further identify patients that are likely to require reintubation by subjecting patients to a burden in addition to that supposed by the spontaneous breathing test. The response to this burden could provide data that might be useful in deciding to extubate and help reduce extubation failure. This study aimed to determine the clinical and gasometric parameters registered during the dead space addition (DSA) test that are most reliable in predicting extubation failure. |
| Ethics approval(s) | Clinical Research Ethical Committee of Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària) (CEIC-IMAS), approved on 12/05/2005. |
| Health condition(s) or problem(s) studied | Acute respiratory failure |
| Intervention | This is a non-randomised, single-arm, pilot study of the dead space addition (DSA) test which aims to detect increased risk of extubation failure. DSA test procedure: The DSA test consisted of adding a tube with an internal volume of 100 cc (measured by filling the tube with water) between the endotracheal tube and the T-piece with oxygen for 30 minutes. At the start of the test, BP, HR, RR, O2 saturation by pulDSA test. |
| Intervention type | Other |
| Primary outcome measure | Clinical signs of increased work of breathing (intercostal retractions, accessory muscle use, nasal flaring) were monitored during the DSA test. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/11/2004 |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 152 |
| Key inclusion criteria | 1. Both males and females, aged 18 or older 2. Improvement of the underlying cause of acute respiratory failure 3. Patients who fulfilled the criteria for extubation recommended by the Consensus Conference on Weaning after the 120-minute spontaneous breathing test: no signs of respiratory insufficiency (paradoxical breathing, abdominal breathing, agitation, excessive sweating, etc.), saturation of oxygen in arterial blood flow (SpO2) >90%, FiO2 <0.5, respiratory rate (RR) <35/min, variation <20% in heart rate (HR) and blood pressure (BP) 4. Adequate gas exchange characterised by partial pressure of oxygen in arterial blood (PaO2) >60 mmHg, fraction of inspired oxygen (FiO2) <0.4 and positive end expiratory pressure (PEEP) <5 cm H2O 5. Glasgow Coma Scale >13 6. Body temperature <38ºC 7. No need for vasoactive or sedative drugs |
| Key exclusion criteria | Tracheostomised patients |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital del Mar
Barcelona
08003
Spain
08003
Spain
Sponsor information
Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària [IMAS]) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Passeig Maritim 25-29
Barcelona
08003
Spain
| Website | http://www.imasbcn.com |
|---|---|
"ROR" |
https://ror.org/03a8gac78 |
Funders
Funder type
Hospital/treatment centre
Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària [IMAS]) (Spain)
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 | 01/11/2009 | Yes | No |
