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Column | Value |
---|---|
Trial registration number | NCT04885517 |
Full text link
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
pietro.caironi@unito.it |
Registration date
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-13 |
Recruitment status
Last imported at : May 6, 2023, 8 p.m. Source : ClinicalTrials.gov |
Unknown |
Study design
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Crossover |
Masking
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: group 1 (covid-19 early pneumonia) - age > 18 - positive sars-cov 2 nasal swab - interstitial pneumonia at either ct scan or chest x-ray - respiratory failure requiring cpap for less than 48 hours - fio2 ≤0.5 and cpap≤10 cmh2o group 2 (covid-19 severe pneumonia) - age > 18 - positive sars-cov 2 nasal swab - interstitial pneumonia at either ct scan or chest x-ray - respiratory failure requiring cpap - signs of severity with cpap 10 cmh2o and fio2 0.5: pulse oximetry (spo2) ≤ 93% associated to either: - dyspnea - two or more signs of increased respiratory effort (respiratory rate ≥25 bpm, use of accessory inspiratory muscles , tirage, intercostal space depression, nasal flaring, expiratory abdominal efforts, paco2 < 35) group 3 (non covid-19 pneumonia) - age > 18 - negative sars-cov 2 nasal swab - ct scan or chest x-ray non compatible with covid-19 associated pneumonia - respiratory failure requiring cpap |
Exclusion criteria
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
group 1 (covid-19 early pneumonia) - concomitant chronic pulmonary disease - chronic heart failure new york heart association (nyha) 3-4 - bacterial pulmonary associated infection (diagnosed or suspected) - pulmonary embolism - acute cardiogenic pulmonary edema - signs of severity with cpap 10 cmh2o and fio2 0.5: spo2≤ 93% associated to either: - dyspnea - two or more signs of increased respiratory effort (respiratory rate ≥25 bpm, use of accessory inspiratory muscles , tirage, intercostal space depression, nasal flaring, expiratory abdominal efforts, paco2 < 35) - at least one sign of respiratory fatigue/decompensation (ph<7.30 with paco2 >45, respiratory rate <15 bpm, paradoxal abdominal breathing, mental status alteration) group 2 (covid-19 severe pneumonia) - concomitant chronic pulmonary disease - chronic heart failure nyha 3-4 - bacterial pulmonary associated infection (diagnosed or suspected) - pulmonary embolism - acute cardiogenic pulmonary edema - at least one sign of respiratory fatigue/decompensation (ph<7.30 with paco2 >45, respiratory rate <15 bpm, paradoxal abdominal breathing, mental status alteration) group 3 (non covid-19 pneumonia) - concomitant chronic pulmonary disease - chronic heart failure nyha 3-4 - bacterial pulmonary associated infection (diagnosed or suspected) - pulmonary embolism - acute cardiogenic pulmonary edema - at least one sign of respiratory fatigue/decompensation (ph<7.30 with paco2 >45, respiratory rate <15 bpm, paradoxal abdominal breathing, mental status alteration) |
Number of arms
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
8 |
Funding
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
San Luigi Gonzaga Hospital |
Inclusion age min
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Italy |
Type of patients
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
72 |
primary outcome
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Esophageal pressure swings at different levels of positive end-expiratory pressure (PEEP) |
Notes
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
Arms
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Spontaneous breathing, Non Rebreathing Mask, seated decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus", "treatment_id": 476, "treatment_name": "Esophageal catheter", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}] |