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Trial - NCT04885517


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

Pietro Caironi, Pr

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"}]