Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
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.
Study design
Prospective non-randomised pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2004
Overall trial end date
31/10/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
152
Participant exclusion criteria
Tracheostomised patients
Recruitment start date
01/11/2004
Recruitment end date
31/10/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital del Mar
Barcelona
08003
Spain
Sponsor information
Organisation
Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària [IMAS]) (Spain)
Sponsor details
Passeig Maritim 25-29
Barcelona
08003
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital del Mar, Municipal Institute for Health Care (Institut Municipal d'Assistència Sanitària [IMAS]) (Spain)
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/19366440
Publication citations
-
Results
Solsona JF, Díaz Y, Vázquez A, Pilar Gracia M, Zapatero A, Marrugat J, A pilot study of a new test to predict extubation failure., Crit Care, 2009, 13, 2, R56, doi: 10.1186/cc7783.