Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
NCT Number: NCT01383213
The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia
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All sexes
Interventional
Not applicable
Milan, 20122, Italy
Pneumonia is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up to 30%.
Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration by Venturi mask for the treatment of severe acute respiratory failure in patients with pneumonia. .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation
Time frame: the reaching of the following endotracheal intubation criteria maintained for at least one hour:
Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion.
The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of:
University of Milan
Other
A Prospective, Randomized, Controlled Trial to Evaluate the Efficacy of CPAP Delivered by Helmet in Comparison With Oxygen Therapy by Venturi Mask in Severe Acute Respiratory Failure Caused by Pneumonia
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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