Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Oct 11, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at three different methods of helping patients who are experiencing severe breathing problems, known as hypoxemic respiratory failure. The study will compare the use of a helmet for noninvasive ventilation, a helmet for continuous positive airway pressure (CPAP), and high-flow nasal oxygen to see which method is most effective in reducing the need for a breathing tube (endotracheal intubation). The trial is open to adults aged 65 to 74 who have acute breathing issues, specifically those with a certain level of low oxygen in their blood.

To participate, patients must show signs of severe respiratory failure but cannot have a history of chronic breathing problems or serious heart issues. Additionally, those who have been on certain breathing support systems for more than 24 hours prior to joining the trial will not be eligible. If someone decides to join, they can expect close monitoring and support throughout the process. The study is currently recruiting participants, and it’s an important opportunity to help improve treatment options for patients with serious breathing difficulties.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA\>2 or left ventricular ejection fraction\<50%); Informed consent
• • Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded.
• Other Exclusion Criteria:
• • Pregnancy;
• • Exacerbation of asthma or chronic obstructive pulmonary disease;
• • Hypercapnia (PaCO2\>45 mmHg) with or without respiratory acidosis;
• • More than 2 organ failures, including the lung.
• • Documented pneumothorax;
• • Clinical diagnosis of Cardiogenic pulmonary edema;
• • Haemodynamic instability (Systolic blood pressure\<90 mmHg or mean arterial pressure\<65mmHg) and/or lactic acidosis (lactate\>5 mmol/L) and/or clinically diagnosed Shock requiring administration of vasoactive agents (norepinephrine\>0.1 mcg/Kg/min);
• • Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
• • Chronic kidney failure requiring dialysis before ICU admission;
• • Chronic hypoxemic respiratory failure requiring long-term oxygen therapy;
• • Altered neurological status that requires immediate intubation and/or making the patient uncooperative;
• • Urgent need for endotracheal intubation, according to the decision of the attending physician;
• • Do not intubate order;
• • Decision of withdrawal of life-sustaining therapy;
• • Thoracic or abdominal surgery in the previous 7 days;
• • Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure;
• • Recent head surgery or anatomy that prevent the application of helmet or HFNC to patient's face.