COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04361435


Column Value
Trial registration number NCT04361435
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Saly Salti, MSc

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

salysalti@hotmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-24

Recruitment status
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

all the patients admitted to the icus during the study period will be screened. we will not set any restrictions regarding the timing of the prescription of cpt (i.e., length of icu stay before screening) for the screening. we will include only if cpt is expected to be used as management at least for the next 24 hours in the icus from the time of inclusion. for instance, if cpt will be expected to be discontinued from the management in a day, we will exclude them from the inclusion. cpt can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside intensivists in charge of the study date. specific inclusion criteria - patients diagnosed as covid-19 - patents strongly suspected its infection and the result of virological testing is pending as of screening. - patients with any type of mechanical ventilation (i.e., invasive, non-invasive, high flow nasal therapy) - patients are on standard oxygen by mask or nasal cannula and the fio2 provided can be measurable. - patients who are on respiratory monitoring at least spo2 can be continuously measurable.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- cpt order will (or is expected to) be discontinued within 12 hours from the inclusion timing. this may include potential discharge from the unit. - cpt is not ordered for airway clearance. - spo2 is not stable (spo2=<80%) with more than 0.60 of fio2 for ventilated patients including patients on niv, at least for the previous 1 hour from the screening. - spo2 is not stable (spo2=<80%) with more than 0.60 of fio2 for the patients on hfnc, at least for the previous 1 hour from the screening. - bradycardia (hr<50bpm) at any intervention at least 24 hours before the screening. - patients with known pneumothorax, osteomyelitis at icu admission. - thoracotomy within 1 month from the admission date. - known recent/unhealed rib fractures. - known skin injury of the chest wall. - no, obtain of ic. - brain death or vegetated states.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

St. Justine's Hospital

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

50

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

SpO2/FIO2 Ratio

Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 902, "treatment_name": "Non-invasive oscillating device", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 271, "treatment_name": "Chest physiotherapy", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]