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

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ClinicalTrials.gov Identifier: NCT03133520
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kursat Gundogan, TC Erciyes University

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

Condition or disease Intervention/treatment Phase
Acute Hypoxemic Respiratory Failure Hematologic Malignancy Device: High flow oxygen therapy Not Applicable

Detailed Description:

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 day-28 mortality


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard oxygen group
This patient groups will receive only routine oxygen therapy. Routine oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.
Experimental: High flow oxygen therapy group
This patients group will receive high flow oxygen therapy. High flow nasal oxygen therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, it 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%.
Device: High flow oxygen therapy
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 Outcome Measures :
  1. Intubation rate [ Time Frame: First seven days ]
    Intubation rate for each group


Secondary Outcome Measures :
  1. Mortality [ Time Frame: First 28 days ]
    All-cause day-28 mortality


Other Outcome Measures:
  1. patients comforts [ Time Frame: First 24 hours ]
    Patient comfort with Visual Analogue Scale (VAS) score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133520


Contacts
Contact: Kursat Gundogan, MD +90 352 207 6666 ext 21919 kgundogan@erciyes.edu.tr
Contact: Nilgün Mendil, MD +90 352 207 6666 ext 20274 namendil@yahoo.com.tr

Locations
Turkey
Erciyes University Medical School Recruiting
Kayseri, Turkey, 38039
Contact: Ismail Kocyigit, MD    +903522076666 ext 20000    ikocyigit@erciyes.edu.tr   
Contact: Mustafa Kula, MD    +903522076666 ext 20001    mkula@erciyes.edu.tr   
Sponsors and Collaborators
Kursat Gundogan

Publications:
Responsible Party: Kursat Gundogan, Associate professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03133520     History of Changes
Other Study ID Numbers: November, 2016
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kursat Gundogan, TC Erciyes University:
Respiratory failure
immuncompromise patients
high flow oxygen

Additional relevant MeSH terms:
Neoplasms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases