A pilot study of a new test to predict extubation failure
| ISRCTN | ISRCTN76206152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76206152 |
| Protocol serial number | N/A |
| Sponsor | Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària [IMAS]) (Spain) |
| Funder | Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària [IMAS]) (Spain) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective non-randomised pilot study |
| Secondary study design | Non randomised controlled trial |
| 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(s) |
Clinical signs of increased work of breathing (intercostal retractions, accessory muscle use, nasal flaring) were monitored during the DSA test. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
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 | 01/11/2009 | Yes | No |
