Health TrialsbyHealthPanel

High Flow Nasal Cannulae vs Venturi Mask in Respiratory Failure Due to Pneumonia

ConditionsRespiratory InsufficiencyPneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPapa Giovanni XXIII Hospital

About this trial

The primary objective of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of reaching of endotracheal intubation criteria during acute respiratory failure due to severe pneumonia.

Inclusion Criteria: Respiratory rate (RR) at rest ≥20 bpm or presence of respiratory distress (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2 / FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure. Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula Oxygenation (75 patients, HFNCO with flow ≥ 60 L/min and FiO2 to maintain SpO2 ≥ ) or Venturi Mask Oxygenation (control, 75 patients).

Patients from both groups will be treated with antibiotic therapy according to the IDSA/ATS 2007 guidelines for community-acquired pneumonia and the IDSA/ATS 2016 guidelines for hospital-acquired pneumonia.

Intubation Criteria:

MAJOR CRITERIA:

Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation

MINOR CRITERIA (maintained for ≥1h):

Reduction ≥30% of the value of the PaO2/FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the achievement of clinical stability, and whenever there is a clinical worsening.

Patients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability, defined as:

Body temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the endotracheal intubation criteria - regardless of the actual intubation rate - within the first 48 hours of treatment. The primary analysis will be performed on the ITT population

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male or female of any ethnic group

age greater than or equal to 18 years;

respiratory rate (RR) at rest ≥ 20 breaths/minute or presence of respiratory distress (severe - dyspnea at rest or use of accessory respiratory muscles or paradox abdominal movement) PaO 2/ FiO 2 ≤250 during oxygen therapy with Venturi mask with FiO 2 50% administered for at least 60 minutes;

diagnosis of pneumonia as the unique cause of acute respiratory failure

Disqualifiers

other diagnoses (instead of pneumonia) as a cause of acute respiratory failure

unstable angina and acute myocardial infarction in place;

Acute respiratory acidosis with pH <7.35 and PaCO 2 > 45 mmHg;

systolic blood pressure <90 mmHg unresponsive to fluids or with amines

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Flow Nasal Cannula Oxygenation

    Device

    Delivery of humidified and heated (37ºC) high flow oxygen

  • Venturi Mask Oxygenation

    Device

    delivery of high flow oxygen

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: High Flow Nasal Cannula OxygenationExperimental treatment 1 intervention
Group B: Venturi Mask OxygenationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Failure

The primary endpoint is the achievement of clinical failure defined as: At least one of major criteria Or At least 2 or more of the minor criteria maintained for at least 1 consecutive hour: MAJOR CRITERIA: Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability (Heart Rate ≤ 50 bpm with loss of alertness or Systolic Blood Pressure ≤ 70 mmHg) Need for sedation MINOR CRITERIA (observed for ≥ 1 hour): Reduction ≥30% of the value of the PaO 2 / FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale (see Appendix II) Persistence or onset of respiratory distress ( severe dyspnea or use of accessories respiratory muscles or paradoxical abdominal motion)

Time frame
Participants will be followed for the duration of hospital stay, for a maximum of 30 days

Secondary outcomes

1

30-day mortality after admission

mortality rate at 30 days after admission

Time frame
day 30
2

improvement of respiratory exchanges compared to baseline

arterial blood gas evaluation of gas exchange and ventilation

Time frame
hospital admission (=day 1), day 2, until the achievement of clinical stability
3

adverse events

observation adverse events rate

Time frame
Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week
4

hospital stay

length of hospital stay

Time frame
Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Papa Giovanni XXIII Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now