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Completed

NCT Number: NCT03133520

Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure

Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Medical School

Kayseri, 38039, Turkey (Türkiye)

About this study

Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.

High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnea and discomfort, decreases in tachypnea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimizing the need for endotracheal intubation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known immunosuppression defined as haematological malignancy.
  • Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2<92%
  • Respiratory distress with a respiratory rate >22/min

Exclusion criteria

  • Refusal of study participation
  • Pregnancy or breastfeeding
  • Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg)
  • Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation)
  • Haemodynamic instability (mean arterial pressure <65 mmHg)
  • Vasopressor needs
  • Awareness confusion and disorientation

Treatment and study plan

High flow oxygen therapy

Device

High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.

Primary outcomes

  1. Intubation rate

    Time frame: First seven days

    Intubation rate for each group

Secondary outcomes

  1. Mortality

    Time frame: First 28 days

    All-cause day-28 mortality

  2. patients comforts

    Time frame: First 24 hours

    Patient comfort with Visual Analogue Scale (VAS) score

Sponsors and collaborators

Lead sponsor

Kursat Gundogan

Other

Registry information

Acronym: HFOT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2017
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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