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Prone versus lateral position in patients with high-flow nasal oxygen therapy: A protocol for a multi-centre randomised controlled open-label trial

Prone versus lateral position in patients with high-flow nasal oxygen therapy: A protocol for a multi-centre randomised controlled open-label trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055822
Enrollment
Unknown
Registered
2022-01-20
Start date
2022-05-16
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

acute respiratory failure

Interventions

control group:Semi-supine position combines with high-flow nasal oxygen therapy
experimental group A:combine prone position with high flow nasal oxygen therapy
experimental group B:combine lateral position with high flow nasal oxygen therapy

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults (Aged 18 years and over) using high flow nasal oxygen therapy; 2. 100mmhg < oxygen index(PO2/FiO2)<= 300mmhg.

Exclusion criteria

Exclusion criteria: 1.Received invasive mechanical ventilation before joining participating in the experiment; 2.Needed immediate intubation based on a doctors assessment; 3.Had a respiratory rate > 40 breaths per minute or < 6-8 breaths per minute; 4.Had irregular breathing; 5.The partial pressure of carbon dioxide increased progressively and the pH value was less than 7.25; 6.Had altered states of consciousness, and or athe GCS score was less than 10 points; 7.Were unable to cooperate or refused to lie in the prone position; 8.Had haemodynamic instability (SB P < 90 mmHg, MBP < 65 mmHg), or needed to use vasoactive drugs; 9.Had deep venous thrombosis or pulmonary embolism; 10.Had acute haemorrhagic disease; 11.Had thoracic and abdominal trauma or, burns, had undergone, surgery within three months or were pregnant; 12.Had a pneumothorax; 13.Had increased intracranial pressure, spinal cord injury or needed to limit the amount of time spent in a non-prone positioning take a certain restrictive position; 14.Refused intubation or resuscitation.

Design outcomes

Primary

MeasureTime frame
All-cause mortality in 28 days;

Secondary

MeasureTime frame
Intubation rate in 28 days;Change in the PaO2/FiO2 ratio;Change in procalcitonin levels;Change in heparin-binding protein levels;Visual analogue scale for dyspnea;Position changing time;Change in the ratio of SpO2/FiO2 to respiratory rate(ROX index);Number of days using HFNO,non-invasive ventilation or invasive ventilation;The incidence of adverse events;Length of hospital and RICU stay;

Countries

China

Contacts

Public ContactZhou Xixin

The Second Affiliated Hospital of Chongqing Medical University

707365202@qq.com+86 23 63693734

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026