Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT06211920 | Unknown DMC

• 1 other identifier: 97289
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD Exacerbation; COPD Exacerbation Acute; Noninvasive Ventilation; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• The 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.

  During the prehospital treatment for a maximum of 2 hours.

Secondary Outcomes (6)

• Overall time with a NIV-mask on.

  From time of randomization and during the entire admission. Assessed up to 30 days.

• Proportion treated with invasive respiratory treatment.

  During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.

• Length of hospital stay.

  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.

  2 hours from the initial prehospital ABG analysis.

• Mortality (in-hospital and 30 days after admission).

  During the length of hospital stay and up until 30 days after admission.

Other Outcomes (3)

• Correlation between venous and arterial pH.

  During the prehospital treatment for a maximum of 2 hours.

• Correlation between PaCO2 and the partial pressure of CO2 in venous blood (PvCO2).

  During the prehospital treatment for a maximum of 2 hours.

• Correlation between "venous to arterial conversion" (v-TAC) and the results from the actual arterial blood gas analysis regarding pH, PaCO2 and PaO2 in all enrolled patients.

  During the prehospital treatment for a maximum of 2 hours.

Study Arms (2)

Non-invasive ventilation (NIV) + standard medical treatment

EXPERIMENTAL

The intervention will consist of application of NIV through a facemask. This will happen 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. These settings are preset on the ventilator used in the physician manned mobile emergency care unit (MECU) in the Central Denmark Region. 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. NIV will be administered together with standard medical treatment described below.

Other: Non-invasive ventilation

Standard medical treatment alone

NO INTERVENTION

The standard treatment may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation. Although this treatment is based on regional standard operating procedures (SOP), it may differ from patient to patient because it is based on the clinical judgement by the emergency physician in the MECU. Inhaled bronchodilators can be given in the form of Fenoterol and Ipratropium as a combination drug and/or Salbutamol. Both as a nebulizer solution. One dose (4 ml) of the combination drug contains 1,25 mg Fenoterol and 0,5 mg Ipratropium. Salbutamol will be administered in a concentration of 1 mg/ml. Five mg will be given initially, which can be repeated if necessary. Corticosteroids can be given in the form of Methylprednisolone 40-80 mg administered intravenously after establishing an intravenous access. Oxygen therapy will be delivered through a nasal cannula if possible or a non-rebreather mask to maintain an arterial saturation of 88-92%.

Interventions

Non-invasive ventilation OTHER

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.

Also known as: Standard medical treatment alone

Non-invasive ventilation (NIV) + standard medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years.
• Medical history of COPD.
• Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
• Respiratory acidosis with a PaCO2 of \> 6,0 kPa and a pH of \< 7,30.
• And one of the following:
• Respiratory rate of \> 25 per minute.
• Hypoxia with a PaO2 \< 7 kPa and/or a saturation \< 88% without oxygen administered.

You may not qualify if:

• Upper gastrointestinal hemorrhage or vomiting.
• Anatomical abnormality that precludes the use of an oro-nasal interface.
• Suspicion of pneumothorax.
• Cardiac or respiratory arrest.
• Uncontrollable malignant arrhythmia.
• Refractory shock (systolic blood pressure \< 90 mmHg) despite fluids and/or vasoactive drugs given.
• Required orotracheal intubation.
• Suspected upper airway obstruction.
• No indication for life-prolonging treatment with NIV.

Sponsors & Collaborators

• Central Denmark Region: lead

Study Sites (1)

Prehospital Emegency Medical Service, Central Denmark Region, Denmark

Aarhus N, Central Jutland, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jesper H Haunstrup Brendel, MD

  Research and development, The Prehospital Department in The Central Denmark Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper H Brendel, MD.

CONTACT

004530504012; jespholb@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, the clinicians performing the intervention cannot be blinded. This is also the case for patients along with any legally designated representatives at the scene. As it is common to note the prehospital treatment in the patient's medical records clinicians at the ED and/or ICU will not necessarily be blinded either. For the same reason, investigators involved in data entry will also not be blinded meaning that outcomes such as change in arterial pH are entered without blinding. However, there is little - if any - subjectivity in evaluating these outcomes and blinding is therefore likely of minor importance. A patient - or alternatively the consenting legally designated representatives - will not be informed of the allocation until the end of follow-up and only per request on the consent form.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator-initiated, randomized 1:1, clinical trial

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 18, 2024
• Study Start: December 8, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 30, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: There will be no predetermined end date for the data sharing.
• Access Criteria: Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator. Authorship of publications emerging from the shared data will follow standard authorship guidelines from the International Committee of Medical Journal Editors and might or might not include authors from the steering committee depending on the nature of their involvement.

Locations

DK (1)