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

Hematologic Malignancy Clinical Trial

— HFOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133520
• Other study ID #: November, 2016
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: September 14, 2018

Study information

• Verified date: June 2020
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 the need for endotracheal intubation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Respiratory Insufficiency

Intervention

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%.

Locations

Country	Name	City	State
Turkey	Erciyes University Medical School	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kursat Gundogan

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Hernández G, Vaquero C, González P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernández R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711. — View Citation

Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0. — View Citation

Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC. — View Citation

Türkoglu M, Erdem GU, Suyani E, Sancar ME, Yalçin MM, Aygencel G, Aki Z, Sucak G. Acute respiratory distress syndrome in patients with hematological malignancies. Hematology. 2013 May;18(3):123-30. doi: 10.1179/1607845412Y.0000000038. Epub 2012 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate	Intubation rate for each group	First seven days
Secondary	Mortality	All-cause day-28 mortality	First 28 days
Secondary	patients comforts	Patient comfort with Visual Analogue Scale (VAS) score	First 24 hours