Acute Lung Injury, Community-Acquired Infections, Pneumonia, Respiratory Insufficiency
Conditions
Keywords
CPAP, community-acquired pneumonia, acute respiratory failure, hypoxemia, Continuous Positive Airway Pressure
Brief summary
The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.
Detailed description
Community-acquired pneumonia (CAP) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%. Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration via a Venturi mask for the treatment of acute respiratory failure in immunocompetent patients with community-acquired pneumonia. Therefore, the aim of this study is to compare the efficacy of CPAP delivered by a helmet and O2 administration via a Venturi mask in terms of gas exchanges improvement in early acute respiratory failure (PaO2/FiO2 between 210 and 285)due to community-acquired pneumonia. A Steering Committee composed by the principal investigators will request an interim analysis at 20% enrolment in order to monitor the criteria for equipoise of the two treatments.
Interventions
PROCEDURECastar Starmed (CPAP) delivered by a helmet
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Community-acquired pneumonia (CAP) defined as: new chest x-ray pulmonary infiltrate, fever, and respiratory symptoms * Acute Hypoxemic Respiratory failure * Respiratory Rate \< 35 breaths/min * PaO2/FiO2 \> 200 and \< 300 while breathing oxygen for at least 15 minutes via a Venturi mask with FiO2 0.5
Exclusion criteria
* Immunosuppression * acute cardiogenic pulmonary edema * Patients belonging to Class II-III-IV of the NYHA * Acute coronary syndrome * Acute Respiratory Acidosis pH \< 7.35 and PaCO2 \> 45 mmHg * More than 3 acute organ failures * Systolic Pressure \< 90 mmHg under fluid resuscitation or vasopressor drug use * Seizures * Decreased level of consciousness (GCS \<12) * Inability to clear secretions * Pre-defined intubation criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 | on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PaO2/FiO2 Ratio Mantainance | 1, 6, 12, 24 and 48 hours | the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement |
Countries
Italy
Participant flow
Recruitment details
The Steering Committee requested an interim analysis at 20% enrollment in order to monitor the criteria for actual equipoise of the two treatments. Being this unplanned, the Lan-DeMets approach was followed and a manifest superiority of the CPAP treatment was identified, with a nominal alpha exceeding the criterion for interruption set at 0.00008.
Participants by arm
| Arm | Count |
|---|---|
| CPAP (Continuous Positive Airway Pressure) CPAP delivered by a helmet | 20 |
| Venturi O2 administration via a conventional Venturi mask | 27 |
| Total | 47 |
Baseline characteristics
| Characteristic | Venturi | CPAP (Continuous Positive Airway Pressure) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 12 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age Continuous | 72 years STANDARD_DEVIATION 13 | 65 years STANDARD_DEVIATION 17 | 69 years STANDARD_DEVIATION 15 |
| Region of Enrollment Italy | 27 participants | 20 participants | 47 participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 27 |
| serious Total, serious adverse events | 0 / 20 | 0 / 27 |
Outcome results
Primary
Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
Time frame: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPAP (Continuous Positive Airway Pressure) | Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 | 405 minute | Standard Deviation 855 |
| Venturi | Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 | 2437 minute | Standard Deviation 1170 |
Comparison: endpoint was analyzed in terms of time by comparison of mean +- SDp-value: <0.001t-test, 2 sided
Secondary
PaO2/FiO2 Ratio Mantainance
the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement
Time frame: 1, 6, 12, 24 and 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP (Continuous Positive Airway Pressure) | PaO2/FiO2 Ratio Mantainance | 19 participants |
| Venturi | PaO2/FiO2 Ratio Mantainance | 8 participants |
p-value: 0.000007Chi-squared