The goal of this clinical trial is to test if treatment with prehospital Non-invasive ventilation (NIV) for patients with acute respiratory failure (ARF), due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) based on in-hospital criteria, should be used in the prehospital setting. This is performed with the introduction of prehospital arterial blood gas analyzation. The primary objective is: • To determine if early prehospital applied NIV together with standard medical treatment will affect arterial pH at hospital arrival in patients with ARF due to AECOPD. Participants in the intervention will receive Non-invasive ventilation together with standard medical treatment. The intervention will be compared to standard medical treatment alone, that may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
The application of NIV will be performed using af a facemask as soon as possible after the patient has been randomized by opening the opaque envelope. All patients will receive the same standardized ventilator settings at initiation. The IPAP will be set at 12 cm H2O and the PEEP at 5 cm H2O. Oxygen delivery will be adjusted to an arterial oxygen saturation of 88-92%. Further adjustment of ventilator settings and evaluation of treatment effect will be at the discretion of the prehospital physician.
Prehospital Emegency Medical Service, Central Denmark Region, Denmark
Aarhus N, Central Jutland, Denmark
RECRUITINGThe change in pH observed during the prehospital treatment period.
pH will be measured before randomization in the prehospital setting and at arrival at the emergency department. The change in pH will be compared between the two groups.
Time frame: During the prehospital treatment for a maximum of 2 hours.
Overall time with a NIV-mask on.
NIV treatment time will be registrered in both groups on a schematic form. The outcome will be compared between the two groups.
Time frame: From time of randomization and during the entire admission. Assessed up to 30 days.
Proportion treated with invasive respiratory treatment.
The outcome will be compared between the two groups.
Time frame: During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.
Length of hospital stay.
The outcome will be compared between the two groups.
Time frame: From time of admission and up until discharge. Assessed up to 30 days.
The change in pH 2 hours from the initial prehospital ABG analysis.
pH will be measured before randomization in the prehospital setting and again after 2 hours. The change in pH will be compared between the two groups.
Time frame: 2 hours from the initial prehospital ABG analysis.
Mortality (in-hospital and 30 days after admission).
The outcome will be compared between the two groups.
Time frame: During the length of hospital stay and up until 30 days after admission.
Prehospital treatment time (both on-scene time and transport time).
The outcome will be compared between the two groups.
Time frame: During the prehospital treatment for a maximum of 2 hours.
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