High-flow Nasal Oxygenation and Non-invasive Ventilation Strategies for the Treatment of Covid-19 Pneumonia

Comparison of High-flow Nasal Oxygenation and Non-invasive Ventilation Strategies for the Treatment of Covid-19 Pneumonia in the Intensive Care Unit: a Prospective Trial.

HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: HFNO and NIV

Detailed Description

Coronavirus 2019 disease (COVID-19) is a deadly infection that causes a new type of severe acute respiratory syndrome. It has been reported that the mortality rate in critically ill patients with a diagnosis of COVID-19 reached 61%. The primary pathology in these patients is progressive hypoxia due to lung injury and associated multi-organ damage. It has been reported that aggressive treatments such as tracheal intubation and classical mechanical ventilation to treat lung injury are not helpful or even harmful. The highest mortality rate was reported as 86% in these patients on mechanical ventilation. Acute respiratory distress syndrome (ARDS) developing in COVID-19 infection is not typical and is estimated to have a different mechanism, therefore it is emphasized that different strategies should be used for the treatment of ARDS in these patients. Two of the most important strategies used in these patients followed in the intensive care unit are high flow nasal oxygenation (High Flow Nasal Oxygenation-HFNO) and non-invasive ventilation (Non-Invasive Ventilation-NIV). HFNO is a method frequently used before intubation in adult patients with acute respiratory failure. It is based on the principle of giving warm and humidified oxygen to the patient through a nasal cannula in the range of 1-70 L/min. Due to the low number of mechanical ventilators in many intensive care units at the beginning of the pandemic, it was used in many COVID-19 patients and was found to be effective in later retrospective analyzes. It has been reported in many studies that HFNO therapy is more effective than conventional mask oxygen therapy. There are publications stating that it is more advantageous compared to NIV as it is easier to apply and more comfortable for the patient. Conventional NIV is called continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (BiPAP) ventilation. It is used as oxygen/ventilation therapy in SARS and H1N1 patients. Studies have reported that it is used in 70% of patients before tracheal intubation in COVID-19 patients. However, mortality was high in these patients.

HFNO and NIV strategies are the most commonly used strategies for the treatment of hypoxia in patients with a diagnosis of COVID-19 who are still followed in the intensive care unit, but there is no study comparing the two yet. In our prospective study, we aimed to compare these two treatment modalities. The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation). Failure will be evaluated as the need for intubation during treatment or the patient's death. Secondary aim is failure of treatment and discharge of patients from intensive care to service or home.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Bagcilar
    • Istanbul, Bagcilar, Turkey, 34070
      • Istanbul Medipol University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This prospective, single-center study will be conducted in the Intensive Care Unit of Medipol Mega Hospital, an academic university hospital. It is planned to include patients over the age of 18 with a diagnosis of COVID 19 (severe respiratory failure and positive PCR test).

Description

Inclusion Criteria:

• PCR (+)
• P/F ≤300 mmHg (despite standard mask oxygen support from 15 L/min for 15 minutes)
• Respiratory rate ≥24/min or signs of respiratory failure (intercostal retraction, nasal wing breathing)

Exclusion Criteria:

• Chronic respiratory failure
• Cardiogenic pulmonary edema
• Aplasia
• GCS ≤12
• Hemodynamic instability (use of vasopressors)
• Emergency intubation requirement

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High Flow Nasal Oxygenation-HFNO; The current will be adjusted from 50-70 liters. The patient's SpO2 value will be maintained at at least 92%. Arterial blood gas will be checked at the 1st hour	Other: HFNO and NIV; Patients meeting the inclusion criteria will be treated alternately with 2 hours of HFNO and 1 hour of NIV (HFNO-NIV for the same patient in turn). In 24 hours, there will be 16 hours of HFNO, 8 hours of NIV. Parameters to record; Respiratory parameters (respiratory rate); SpO2; Ventilator settings; Patient's tolerance (VAS; between 0-100); Arterial blood gas (HFNO and NIV at 1 hour); Clinical parameters (D dimer, CRP, ROX index) Intubation criteria; Loss of consciousness; Agitation; Persistent hypotension; Need for fluid resuscitation; Need for vasopressor; Respiration rate ≥40/min; SpO2 <92; pH<7.30
Non-Invasive Ventilation-NIV; Tidal volume will be adjusted to be 6-8 ml/kg. The respiratory rate will be <30. The patient's SpO2 value will be maintained at at least 92%. The PEEP value will be 5 cmH2O. At the 1st hour, arterial blood gas will be checked.	Other: HFNO and NIV; Patients meeting the inclusion criteria will be treated alternately with 2 hours of HFNO and 1 hour of NIV (HFNO-NIV for the same patient in turn). In 24 hours, there will be 16 hours of HFNO, 8 hours of NIV. Parameters to record; Respiratory parameters (respiratory rate); SpO2; Ventilator settings; Patient's tolerance (VAS; between 0-100); Arterial blood gas (HFNO and NIV at 1 hour); Clinical parameters (D dimer, CRP, ROX index) Intubation criteria; Loss of consciousness; Agitation; Persistent hypotension; Need for fluid resuscitation; Need for vasopressor; Respiration rate ≥40/min; SpO2 <92; pH<7.30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the treatment	The primary goal is that the treatment is successful (weaned off HFNO/weaned off NIV: No need for HFNO or NIV and the patient recovers without the need for intubation).	Through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Medipol University

Publications and helpful links

General Publications

• Calligaro GL, Lalla U, Audley G, Gina P, Miller MG, Mendelson M, Dlamini S, Wasserman S, Meintjes G, Peter J, Levin D, Dave JA, Ntusi N, Meier S, Little F, Moodley DL, Louw EH, Nortje A, Parker A, Taljaard JJ, Allwood BW, Dheda K, Koegelenberg CFN. The utility of high-flow nasal oxygen for severe COVID-19 pneumonia in a resource-constrained setting: A multi-centre prospective observational study. EClinicalMedicine. 2020 Nov;28:100570. doi: 10.1016/j.eclinm.2020.100570. Epub 2020 Oct 6.
• Frat JP, Brugiere B, Ragot S, Chatellier D, Veinstein A, Goudet V, Coudroy R, Petitpas F, Robert R, Thille AW, Girault C. Sequential application of oxygen therapy via high-flow nasal cannula and noninvasive ventilation in acute respiratory failure: an observational pilot study. Respir Care. 2015 Feb;60(2):170-8. doi: 10.4187/respcare.03075. Epub 2014 Oct 7.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Medipol Hospital 22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No