Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
NCT Number: NCT06795971
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From randomization to 28 days
The proportion of patients who intubation-free and alive within 28 days after randomization.
Time frame: From randomization to 28 days
The proportion of patients who are died within 28 days
Time frame: From randomization to 28 days
The proportion of patients who are intubated within 28 days after randomization
Time frame: From randomization to 28 days
Priority sequence: 28-day mortality, followed by 28-day intubation
Time frame: From randomization to 28 days
The proportion of patients who meeting the prespecified criteria for intubation within 28 days.
Time frame: From randomization to ICU discharge, assessed up to 60 days
The proportion of patients who died within the ICU
Time frame: From randomization to hospital discharge, assessed up to 60 days
The proportion of patients who died within the hospital
Time frame: Time from randomization to 1hour
The discomfort scale are calculated using 100-mm visual-analogue scale
Time frame: From randomization to 28 days
Days alive without endotracheal intubation and invasive mechanical ventilation
Time frame: From randomization to 28 days
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)
Time frame: From randomization to 28 days
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
Time frame: From randomization to 28 days
The number of ICU-free days within 28 days after randomization
Time frame: From randomization to 28 days
The number of Hospital-free days within 28 days after randomization
Time frame: From randomization to 28 days
The proportion of patients with vomiting, judged by the clinicians according to the clinical manifestations.
Time frame: From randomization to 28 days
The proportion of patients with aspiration of gastric contents, judged by the clinicians according to the clinical manifestations.
Time frame: From randomization to 28 days
The proportion of patients with nasal/facial skin necrosis, judged by the clinicians according to the clinical manifestations.
Time frame: From randomization to 28 days
Pneumothorax detected through chest X-ray or CT scan
Time frame: From randomization to 28 days
The proportion of patients with cardiac arrest
Time frame: From randomization to 28 days
The proportion of other adverse events related to the interventions assessed by investigators
Contact information is provided by the study sponsor or research team.
Ling Liu, PhD
CONTACT
Yi Yang, PhD
CONTACT
Southeast University, China
Other
Acronym: TRIPOD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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