Pneumonia, Respiratory Insufficiency
Conditions
Keywords
Acute Respiratory Failure, Pneumonia, 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 achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia
Detailed description
Pneumonia is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up to 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 by Venturi mask for the treatment of severe acute respiratory failure in patients with pneumonia. .
Interventions
OTHEROxygen therapy
patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
OTHERHelmet CPAP
patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation
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
* men and women of any ethnic group; * age ≥18 years; * dyspnoea at rest with respiratory rate (RR) ≥30 breath/min or sign of respiratory distress * PaO2/FiO2 ratio≤250 evaluated during oxygen therapy supplied at least 1 hour through a Venturi mask with FiO2 ≥0,50 * diagnosis of pneumonia as unique cause of severe acute respiratory failure * informed consent from each patient or from the closest relative in case of the patient's incapacity to give it
Exclusion criteria
* diagnosis of other causes of severe acute respiratory failure * unstable angina or acute myocardial infarction; * acute respiratory acidosis with pH \<7,35 and PaCO2 \>45 mmHg; * systolic BP \<90 mmHg despite fluid resuscitation or vasopressors; * severe arrhythmias; * convulsions; * degree of consciousness, Kelly score\>3; * swallowing disturbance with increasing risk of aspiration pneumonia; * inability to protect the airway; * recent facial trauma or burn; * non-collaborative patient; * presence of open wounds (head, thorax, abdomen); * respiratory arrest or need of intubation; * pregnancy or suspect of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation. | the reaching of the following endotracheal intubation criteria maintained for at least one hour: | Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2\<90%;Exhaustion. The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of: 1. CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint 2. Control: patients randomised to Venturi mask treatment 3. Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP |
Countries
Italy
Participant flow
Recruitment details
Feb. 2010-feb 2013 5 Italian High Dependence Units
Pre-assignment details
Exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| CPAP (Group A) group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92% | 40 |
| Oxygen Therapy (Group B) group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%. | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Oxygen Therapy (Group B) | CPAP (Group A) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 20 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 20 Participants | 33 Participants |
| Age, Continuous | 69.5 years STANDARD_DEVIATION 15.8 | 64.9 years STANDARD_DEVIATION 16.1 | 67.2 years STANDARD_DEVIATION 16 |
| Region of Enrollment Italy | 41 participants | 40 participants | 81 participants |
| Sex: Female, Male Female | 12 Participants | 16 Participants | 28 Participants |
| Sex: Female, Male Male | 29 Participants | 24 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 41 |
| serious Total, serious adverse events | 2 / 40 | 7 / 41 |
Outcome results
Primary
to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.
Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2\<90%;Exhaustion. The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician.
Time frame: the reaching of the following endotracheal intubation criteria maintained for at least one hour:
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP (Group A) | to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation. | 6 participants |
| Oxygen Therapy (Group B) | to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation. | 26 participants |
Secondary
to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality
The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of: 1. CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint 2. Control: patients randomised to Venturi mask treatment 3. Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks