Condition category
Respiratory
Date applied
26/03/2009
Date assigned
11/05/2009
Last edited
26/10/2011
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 Willi Schmidbauer

ORCID ID

Contact details

Scharnhorststraße 13
Berlin
10115
Germany
+49 (0)89 2841 2053
willi-schmidbauer@web.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03 K4-S-170607

Study information

Scientific title

Pre-hospital use of non-invasive ventilation improves acute respiratory failure: a randomised controlled trial

Acronym

Study hypothesis

Non-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

Ethics Committee of Charite - University Medicine Berlin gave approval (ref: EA1/140/06)

Study design

Prospective randomised pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute respiratory failure

Intervention

Patients 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 type

Drug

Phase

Not Applicable

Drug names

Fenoterol, reproterol, terbutaline, prednisolone, theophylline, furosemide, nitroglycerin, morphine

Primary outcome measures

Rate of endotracheal intubation during first 24 hours of treatment.

Secondary outcome measures

1. 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 trial start date

01/04/2007

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Pre-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%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients

Participant exclusion criteria

1. 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

Recruitment start date

01/04/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Scharnhorststraße 13
Berlin
10115
Germany

Sponsor information

Organisation

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

Sponsor details

Dachauerstraße 128
Munich
80637
Germany
+49 (0)89 1249 7950
SanABw@bwb.org

Sponsor type

Government

Website

http://www.sanitaetsdienst-bundeswehr.de

Funders

Funder type

Government

Funder name

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

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20844095

Publication citations

  1. Results

    Schmidbauer W, Ahlers O, Spies C, Dreyer A, Mager G, Kerner T, Early prehospital use of non-invasive ventilation improves acute respiratory failure in acute exacerbation of chronic obstructive pulmonary disease., Emerg Med J, 2011, 28, 7, 626-627, doi: 10.1136/emj.2009.089102.

Additional files

Editorial Notes