Official Title
Early Extubation for Patients With Acute Hypoxemic Respiratory Failure
Brief Summary

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.

Detailed Description

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

Recruiting
Mechanical Ventilation
Corona Virus Infection

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.
Helmet non invasive ventilation (NIV)

Eligibility Criteria

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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

University of Chicago Medical Center
Chicago, Illinois, 60637

Recruiting

Investigator: Bhakti Patel, MD
bpatel@medicine.bsd.uchicago.edu


Investigator: Anne Pohlman, MSN
apohlman@medicine.bsd.uchicago.edu

Contacts

Bhakti Patel, MD
773-702-6800 3349
bpatel@medicine.bsd.uchicago.edu

Anne Pohlman, MSN
773-702-3804
apohlman@medicine.bsd.uchicago.edu

University of Chicago
NCT Number
Keywords
helmet interface NIV
early extubation
acute hypoxemic respiratory failure
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Insufficiency