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Trial - NCT05109624


Column Value
Trial registration number NCT05109624
Full text link
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05109624

First author
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Amr Fouad, MD

Contact
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

amr_foud@med.asu.edu.eg

Registration date
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

2021-11-05

Recruitment status
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - - american society of anesthesiologists (asa) physical status ii- iii. - sex (male and females). - age 18 -80 years. - sever adult respiratory distress (ards) (defined as a pao2:fio2 ratio of <150 mm hg, with a fraction of inspired oxygen (fio2) of ≥0.6, a positive end expiratory pressure (peep) of ≥5 cmh2o, and a tidal volume of 6 ml/kg of predicted body weight - mechanical ventilation for less than 36 hours

Exclusion criteria
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

- - contraindication for prone positioning - increased intracranial tension. - face trauma or surgery. - recent deep venous thrombosis - unstable spine, femur, or pelvic fractures - mean arterial pressure < 65 mm hg - pregnant women - pneumothorax - prone positioning before inclusion - those returned to supine position before completing the session time

Number of arms
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Ain Shams University

Inclusion age min
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

52

primary outcome
Last imported at : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Incidence of complications;rate of successful weaning

Notes
Last imported at : Nov. 8, 2021, 3:30 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 : Nov. 8, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1026, "treatment_name": "Prolonged prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]