Early Extubation for Patients With Acute Hypoxemic Respiratory Failure

NCT04349332 | Withdrawn DMC FDA Device

• 1 other identifier: IRB20-0594
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Corona Virus Infection

Keywords

helmet interface NIV; early extubation; acute hypoxemic respiratory failure

Outcome Measures

Primary Outcomes (1)

• ventilator days

  duration of mechanical ventilation via endotracheal tube

  up to 4 weeks

Secondary Outcomes (2)

• Intensive care unit (ICU) length of stay

  up to 6 weeks

• need for re-intubation

  up to 6 weeks

Other Outcomes (8)

• hospital length of stay

  up to 6 weeks

• hospital mortality

  up to 6 weeks

• long term mortality

  up to 1 year

Study Arms (2)

Helmet non invasive ventilation (NIV)

ACTIVE COMPARATOR

Patients randomized to the intervention group will be extubated to helmet NIV.

Device: Helmet non-invasive ventilation (NIV)

Control invasive mechanical ventilation

NO INTERVENTION

Patients randomized to the control group will continue invasive mechanical ventilation. Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes. If the spontaneous breathing trial is successful, then the patient will be extubated.

Interventions

Helmet non-invasive ventilation (NIV) DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized trial

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: August 13, 2020
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)