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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47620321

Enrollment

Registered

2009-05-11

Start date

2007-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory failure Respiratory Respiratory failure, not elsewhere classified

Interventions

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 inclu

Eligibility

Sex/Gender

All

Inclusion criteria

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%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Rate of endotracheal intubation during first 24 hours of treatment.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026