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Effectiveness of lying face down in improving the outcome of COVID-19 patients

Effectiveness of awake self proning strategy in COVID-19: An open-labelled randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025804
Enrollment
120
Registered
2020-06-11
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: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Awake self proning strategy: The COVID-19 patient will be asked to be in prone position and its effect on improvement of their blood oxygenation will be seen using a finger saturation p

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. >18 years of age 2. Diagnosed as COVID-19 positive by RT- PCR 3. Oxygen saturation 4. Can communicate and self-prone

Exclusion criteria

Exclusion criteria: 1. Any patient requiring immediate intubation and ventilatory care 2. Hemodynamic instability BP 3. Elevated intracranial pressure 4. Altered sensorium or history of seizures 5. Any psychiatric comorbidity 6. Massive hemoptysis in the last 48 hours ( >500 ml or requiring transfusion) 7. Morbid obesity where self-proning is not feasible 8. Pregnancy 9. Patients at high risk of requiring CPR or defibrillation (Known arrhythmias)

Design outcomes

Primary

MeasureTime frame
Primary outcomes (Phase 1 study): 1. Oxygen saturation measured using by pulse oximeter at 0, 10, 20, 30, 40 minutes Primary Outcomes (Phase 2 study): 1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death 2. Mortality up to 30 days after enrolmentTimepoint: Primary outcomes (Phase 1 study): 1. Oxygen saturation measured using by pulse oximeter at 0, 10, 20, 30, 40 minutes Primary Outcomes (Phase 2 study): 1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death 2. Mortality up to 30 days after enrolment

Secondary

MeasureTime frame
For phase 2 study: Phase 2 study: 1. Time to endotracheal intubation/ventilation measured using hospital record at discharge. 2. Duration of requirement of oxygen support measured using clinical proforma at patient discharge 3. Duration of hospital stay measured using using hospital record at dischargeTimepoint: Secondary outcome will be measured at patients at patients discharge or death.

Countries

India

Contacts

Public ContactDr Maya Gopalakrishnan

All India Institute of Medical Sciences- Jodhpur

maya.gopalakrishnan@gmail.com9994492075

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026