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Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Patients will receive continuous positive airway pressure |
|
| High-flow nasal oxygen | Active Comparator | Patients will receive high-flow nasal oxygen |
|
| Non-invasive ventilation | Active Comparator | Patients will receive non-invasive ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation-free survival rate | The proportion of patients who intubation-free and alive within 28 days after randomization. | From randomization to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | The proportion of patients who are died within 28 days | From randomization to 28 days |
| Intubation rate within 28 days | The proportion of patients who are intubated within 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Vomiting | The proportion of patients with vomiting, judged by the clinicians according to the clinical manifestations. | From randomization to 28 days |
| Aspiration of gastric contents | The proportion of patients with aspiration of gastric contents, judged by the clinicians according to the clinical manifestations. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Liu, PhD | Contact | +8613851435472 | liulingdoctor@126.com | |
| Yi Yang, PhD | Contact | +8613913966300 | yiyiyang2004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Liu, PhD | Zhongda Hospital, School of Medicine, Southeast University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, School of Medicine, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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|
| High-flow nasal oxygen | Device |
|
|
| Non-invasive ventilation | Device |
|
|
| From randomization to 28 days |
| A ranked composite score incorporating death and intubation through day 28 | Priority sequence: 28-day mortality, followed by 28-day intubation | From randomization to 28 days |
| Meeting the prespecified criteria for intubation within 28 days. | The proportion of patients who meeting the prespecified criteria for intubation within 28 days. | From randomization to 28 days |
| ICU mortality | The proportion of patients who died within the ICU | From randomization to ICU discharge, assessed up to 60 days |
| In-hospital mortality | The proportion of patients who died within the hospital | From randomization to hospital discharge, assessed up to 60 days |
| Change in Discomfort scale after 1 hour of randomization | The discomfort scale are calculated using 100-mm visual-analogue scale | Time from randomization to 1hour |
| Invasive ventilator-free days at 28 days | Days alive without endotracheal intubation and invasive mechanical ventilation | From randomization to 28 days |
| Circulatory support-free days at day 28 | Circulatory support defined as infusion of any vasopressor/inotrope agent for a minimum of 1 hour (i.e. norepinephrine, epinephrine, phenylephrine, vasopressin analogues, angiotensin, dopamine, dobutamine, milrinone or levosimendan) | From randomization to 28 days |
| Time from randomization to an improvement of two points on a seven-category ordinal scale | 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death | From randomization to 28 days |
| ICU-free days at day 28 | The number of ICU-free days within 28 days after randomization | From randomization to 28 days |
| Hospital-free days at day 28 | The number of Hospital-free days within 28 days after randomization | From randomization to 28 days |
| From randomization to 28 days |
| Nasal/facial skin necrosis | The proportion of patients with nasal/facial skin necrosis, judged by the clinicians according to the clinical manifestations. | From randomization to 28 days |
| Pneumothorax | Pneumothorax detected through chest X-ray or CT scan | From randomization to 28 days |
| Cardiac arrest | The proportion of patients with cardiac arrest | From randomization to 28 days |
| Other adverse events | The proportion of other adverse events related to the interventions assessed by investigators | From randomization to 28 days |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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