Condition category
Respiratory
Date applied
07/08/2008
Date assigned
04/12/2008
Last edited
21/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Felipe J Solsona

ORCID ID

Contact details

Hospital del Mar
Institut Municipal d'Assistència Sanitària (IMAS)
Passeig Maritim 25-29
Barcelona
08003
Spain

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

http://www.imasbcn.com

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

  1. 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.

Additional files

Editorial Notes