The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.
Single center randomized clinical trial investigating the efficacy of helmet NIV used for
early liberation from mechanical ventilation in patients with acute hypoxemic respiratory
failure.
Intervention: Helmet group Patients randomized to the intervention group will be extubated to
helmet NIV without a spontaneous breathing trial. The helmet will be connected to oxygen and
room air flow meter to deliver a minimum of 60L of fresh gas flow and a PEEP valve. The PEEP
will be increased using a PEEP valve in increments of 2-3 cmH20 to improve peripheral oxygen
saturation of at least 90% at an inspired oxygen requirement (FiO2) of ≤ 60%.14 After
application of the helmet, arterial blood gas sampling will be utilized to follow
gas-exchange; this is a part of usual care for the management of patients with acute
hypoxemic respiratory failure. Noninvasive support will be reduced progressively in
accordance to clinical improvement and will be discontinued if patient maintains respiratory
rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If
endotracheal intubation is required, the helmet will be removed and the patient will be
intubated without delay.
Control: Usual Care Patient randomized to the control group will continue invasive mechanical
ventilation until the following weaning criteria are met:15 Resolution or improvement of the
condition leading to intubation Hemodynamic stability, defined as systolic blood pressure
between 90 and 160 mm Hg and heart rate less than 140/min without vasopressors or with low
doses of vasopressors Glasgow Coma Scale score of 13 or greater Respiratory stability (oxygen
saturation >90% with fraction of inspired oxygen [Fio2] ≤0.4, respiratory rate <35/min,
Noncopious secretions (<3 aspirations in the last 8 hours).
Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30
minutes on pressure support mode. Criteria for failure to tolerate the SBT were agitation,
anxiety, low level of consciousness (Glasgow Coma Scale score <13), respiratory rate higher
than 35/min and/or use of accessory muscles, oxygen saturation by pulse oximetry less than
90% with Fio2 higher than 0.5, heart rate higher than 140/min or greater than a 20% increase
from baseline, systolic blood pressure lower than 90 mm Hg, or development of arrhythmia. If
the spontaneous breathing trial is successful, then the patient will be extubated.
Subjects will be followed for long term followup at 90 day and 1year mortality
Device: Helmet non-invasive ventilation (NIV)
After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Inclusion Criteria:
Age ≥18 years old on mechanical ventilation for at least 48 hours Positive End Expiratory
Pressure (PEEP) level between 8 to 13cm H20 The ratio between the partial pressure of
oxygen and fraction of inspired oxygen (PaO2/FiO2) between 150 and 300 mmHg with FiO2≤0.6
pH≥7.25 Respiratory rate (RR)≤30/min Adequate gag and cough reflex Ability to spontaneously
breathe
Exclusion Criteria:
Hemodynamic instability (Systolic blood pressure <90 or requiring >2 vasoactive agents)
Tracheostomy Upper airway obstruction Pregnancy Elevated intracranial pressure Upper airway
obstruction Glasgow coma scale ≤ 8 Patients who refuse to undergo endotracheal intubation,
whatever the initial therapeutic approach
University of Chicago Medical Center
Chicago, Illinois, United States
Investigator: Bhakti Patel, MD
bpatel@medicine.bsd.uchicago.edu
Bhakti Patel, MD
773-702-6800 - 3349
bpatel@medicine.bsd.uchicago.edu
Anne Pohlman, MSN
773-702-3804
apohlman@medicine.bsd.uchicago.edu