Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04349332
Other study ID # IRB20-0594
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 13, 2020
Est. completion date January 9, 2024

Study information

Verified date April 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 9, 2024
Est. primary completion date January 9, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States University of Chicago Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other hospital length of stay number of days spent in hospital during enrollment hospitalization up to 6 weeks
Other hospital mortality death from any cause during hospitalization time of enrollment up to 6 weeks
Other long term mortality death from any cause 90 day, 1year up to 1 year
Other ICU related complications including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness up to 6 weeks
Other discharge location measure the location (home, rehabilitation center, nursing home) up to 90 days
Other health care utilization days alive and institution free up to 6 weeks
Other diaphragm ultrasound thickness ultrasound measurement at end expiration: enrollment, pre extubation, post extubation up to 6 weeks
Other diaphragm thickening fraction ultrasound measurement at end expiration and inspiration to calculate thickening fraction up to 6 weeks
Primary ventilator days duration of mechanical ventilation via endotracheal tube up to 4 weeks
Secondary Intensive care unit (ICU) length of stay number of days admitted to the ICU up to 6 weeks
Secondary need for re-intubation number of patients requiring endotracheal intubation after extubation up to 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT05921656 - Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Withdrawn NCT04288076 - The Brain and Lung Interaction (BALI) Study N/A
Completed NCT03031860 - Semi-quantitative Cough Strength Score (SCSS) N/A
Completed NCT02312869 - Local Assessment of Management of Burn Patients N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01204281 - Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients Phase 4
Terminated NCT01059929 - Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU) Phase 4
Completed NCT00824239 - Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients Phase 3
Completed NCT00529347 - Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern Phase 1
Unknown status NCT00260676 - Protective Ventilatory Strategy in Potential Organ Donors Phase 3
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Completed NCT03281785 - Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients. N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT04410783 - The Emergency Department Sedation Pilot Trial N/A
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A
Completed NCT03930147 - Ventilation With ASV Mode in Children N/A
Recruiting NCT05029167 - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study) N/A
Recruiting NCT04849039 - Lung Microbiota and VAP Development (PULMIVAP)