Effect of prone position cushion combined with external diaphragm pacemaker in elderly patients with severe COVID-19

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068220

Enrollment

Unknown

Registered

2023-02-10

Start date

2023-02-13

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

COVID-19

Interventions

A group:Regular prone position

B group:prone position cushion

C group:prone position cushion + external diaphragm pacemaker

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the 2020 Novel Coronavirus Pneumonia Treatment Protocol (Trial Version 9): positive nucleic acid for novel coronavirus by real-time fluorescence RT-PCR or viral gene sequencing with high homology to known novel coronavirus; 2. Aged >= 60 years; 3. Presenting with shortness of breath, RR >= 30 beats/min or resting state finger oxygen saturation <= 93% or oxygenation index [arterial partial pressure of oxygen (PaO2)/inhaled oxygen concentration (FiO2)] <= 300 mmHg; 4. The patients themselves and their families agreed to enroll and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The risk of airway obstruction or even asphyxia; 2. Respiratory failure due to cardiogenic pulmonary edema; 3. The presence of injuries or wounds on the ventral body surface that interfere with the implementation of the prone position; 4. Having unstable fractures of the cervical spine or spinal column that require immobilization; 5. The presence of glaucoma or other conditions of rapidly elevated intraocular pressure; 6. The presence of increased cranial pressure due to cranial injury, etc.; 7. Presence of significant high risk of pulmonary embolism; 8. Acute bleeding disorders; 9. Severe oxygenation disorders with an oxygenation index [arterial partial pressure of oxygen (PaO2)/inhaled oxygen concentration (FiO2)] 40 breaths/min; 11. Hemodynamic instability requiring vasoactive drugs (systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg despite adequate volume resuscitation); 12. Communication problems, such as severe hearing, visual, cognitive or speech impairment; 13. Participation in other relevant clinical studies within 3 months.

Design outcomes

Primary

Measure	Time frame
Blood oxygen saturation;Oxygenation index;heart rate;Breathing rate;Blood pressure;	—

Secondary

Measure	Time frame
Mortality;	—

Countries

China

Contacts

Public ContactXiaohua Ke

Shanghai Fourth People's Hospital

kxh22@tongji.edu.cn+86 166 2171 9878

Outcome results

None listed

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