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The lying in prone position effect on oxygen saturation in patients in early stage and not intubated having mild to moderate Lung Disease with COVID-19

The effect on oxygen saturation in Early self-proning in awake, non-intubated patients with mild to moderate ARDS COVID-19

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029130
Enrollment
48
Registered
2020-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Prone positionioning: Patient will be asked to lie in prone position for a minimum of three hours in a day and maximum as much as and as many time as he can the patient can tolerate. Th

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. COVID-19 induced mild to moderate ARDS 2. Onset within one week of COVID-19 3. SpO2/FiO2 140-315 4. PF Ratio 100-300 mmHg 5. Bilateral changes on chest imaging 6. Not fully explained by cardiac failure 7. Patients between the ages of 18-75 years 8. Male and female 9. BMI 18-30kg/m2 10. Oxyhemoglobin saturation (SpO2)

Exclusion criteria

Exclusion criteria: 1 Need for immediate intubation 2 RR >40 3 PaO2/FiO2 4 SpO2/FiO2 5 Obvious accessory muscle use 6 HR >100 7 Systolic BP 8 Unable/unwilling to participate to trial 9 Unreliable SpO2 Trace 10 Pregnancy >20/40 gestation 11 Altered mental status with inability to turn in bed without assistance 12 Multi-organ failure 13 Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, severe brain injury). 14 Unable to maintain prone position

Design outcomes

Primary

MeasureTime frame
Primary outcome will be the change in oxygenation (arterial partial pressure of oxygen [PaO2]/FiO2 ratio) ratio as an index of pulmonary recruitment 1 hour after initiation of the prone position.Timepoint: Primary outcome will be the change in oxygenation (arterial partial pressure of oxygen [PaO2]/FiO2 ratio) ratio as an index of pulmonary recruitment 1 hour after initiation of the prone position.—

Secondary

MeasureTime frame
Secondary outcomes will be changes in HRCT at time points SP1 and 4 days after the start of PP. The safety and feasibility of prone positioning (prone position lasting at least 3 h), effect of prone positioning on arterial partial pressure of carbon dioxide (PaCO2) and dyspnoea, and predictors of response to the prone position (ie, differences between responders and non-responders). Responders will be defined as patients with an increased PaO2/FiO2 ratio from for the main analysis.Timepoint: Start po intervention upto 28 days—

Countries

India

Contacts

Public ContactShagufta Naaz

AIIMS Patna

drshaguftanaaz@gmail.com07765937919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026