Pre-hospital use of non-invasive ventilation improves acute respiratory failure

ISRCTN ISRCTN47620321
DOI https://doi.org/10.1186/ISRCTN47620321
Secondary identifying numbers 03 K4-S-170607
Submission date
26/03/2009
Registration date
11/05/2009
Last edited
26/10/2011
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 Willi Schmidbauer
Scientific

Scharnhorststraße 13
Berlin
10115
Germany

Phone +49 (0)89 2841 2053
Email willi-schmidbauer@web.de

Study information

Study designProspective randomised pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePre-hospital use of non-invasive ventilation improves acute respiratory failure: a randomised controlled trial
Study objectivesNon-invasive ventilation (NIV) is used as ventilatory support without endotracheal intubation to spontaneously breathing patients and has been demonstrated to be feasible during hospital treatment of several forms of acute respiratory failure.

The aim of this study is to determine whether the early pre-hospital use of an emergency ventilator, enabling application of continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV) - according to clinical demand - is practicable and will improve dyspnoea.
Ethics approval(s)Ethics Committee of Charite - University Medicine Berlin gave approval (ref: EA1/140/06)
Health condition(s) or problem(s) studiedAcute respiratory failure
InterventionPatients were assigned to one of two groups by closed envelope randomisation:
1. NIV (intervention group)
2. Standard oxygen therapy via face mask (control group)

In both groups, basic therapy included fenoterol, reproterol, terbutaline, prednisolone, theophylline, furosemide, nitroglycerin, and morphine according to clinical necessity and local standard operating procedures. Pre-hospital monitoring consisted of non-invasive arterial blood pressure, continuous pulse oxymetry, continuous electrocardiography (ECG), and 12-channel ECG.

The dyspnoea score measures the dyspnoea as declared by the patient with a range from 1 (no dyspnoea) to 10 (worst dyspnoea with the feeling of asphyxiation).

In addition to the above mentioned drug treatment, patients of the NIV group were initially supplied with CPAP of 5 cm H2O and an inspiratory oxygen fraction (FiO2) of 0.5 (Oxylog® 3000, Draeger Medical, Germany). NIV was applied via face mask, as this has been shown to be favourable compared to nasal masks. Goals of NIV therapy were improvement of dyspnoea score, reduction of respiratory rate less than 25/min, increase of SpO2 greater than 90%, decrease of and acceptance by the patients. In case of failure to reach these treatment goals, CPAP was increased primarily to 7.5 cm H2O and secondarily to 10 cm H2O. Next step of escalation was an additional application of pressure support of 5 cm H2O in the NIPPV modus. If necessary, pressure support was increased by steps of 5 cm H2O up to a peak inspiratory pressure (CPAP + pressure support) of 30 cm H2O. Last step of escalation of NIV treatment was an increase of FiO2 to 1.0. In case of failing the above mentioned goals or intolerance by the patient, NIV treatment was stopped and patient was excluded.

Patients of the control group were supplied by oxygen inhalation via face mask up to 12 l/min. In both groups endotracheal intubation was performed according physicians decision.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Fenoterol, reproterol, terbutaline, prednisolone, theophylline, furosemide, nitroglycerin, morphine
Primary outcome measureRate of endotracheal intubation during first 24 hours of treatment.
Secondary outcome measures1. Difference of baseline and admission values of:
1.1. Pulse oxymetric oxygen saturation
1.2. Respiratory rate
1.3. Dyspnoea score
1.4. Heart rate
1.5. Systolic diastolic arterial blood pressure
2. Duration of intensive care
3. Incidence and duration of mechanical ventilation, and hospital days
4. Feasibility of NIV was rated at a scale from 1 to 5 (very good, good, acceptable, difficult, not feasible)
Overall study start date01/04/2007
Completion date01/10/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30 patients
Key inclusion criteriaPre-hospital patients:
1. Aged above 18 years, either sex
2. Acute dyspnoea
3. Respiratory rate greater than 25/min
4. Pulse oxymetric oxygen saturation less than 90%
Key exclusion criteria1. Refusal of NIV
2. Vomiting
3. Glasgow Coma Scale less than 12 points
4. Suspected myocardial ischaemia
5. Systolic blood pressure less than 100 mmHg
6. Pregnancy
7. Injury of face or neck
8. Participation in another study
Date of first enrolment01/04/2007
Date of final enrolment01/10/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Scharnhorststraße 13
Berlin
10115
Germany

Sponsor information

Medical Service of the Bundeswehr (Sanitätsamt der Bundeswehr [SanABw]) (Germany)
Government

Dachauerstraße 128
Munich
80637
Germany

Phone +49 (0)89 1249 7950
Email SanABw@bwb.org
Website http://www.sanitaetsdienst-bundeswehr.de
ROR logo "ROR" https://ror.org/04y9zrf69

Funders

Funder type

Government

Medical Service of the Bundeswehr (Sanitätsamt der Bundeswehr [SanABw]) (Germany) (ref: 03 K4-S-170607)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2011 Yes No