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

NCT03133520 | Completed

• 1 other identifier: November, 2016
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Hypoxemic Respiratory Failure; Hematologic Malignancy

Keywords

Respiratory failure; immuncompromise patients; high flow oxygen

Outcome Measures

Primary Outcomes (1)

• Intubation rate

  Intubation rate for each group

  First seven days

Secondary Outcomes (2)

• Mortality

  First 28 days

• patients comforts

  First 24 hours

Study Arms (2)

Standard oxygen group

NO INTERVENTION

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%.

High flow oxygen therapy group

EXPERIMENTAL

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

Interventions

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%.

High flow oxygen therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kursat Gundogan: lead

Study Sites (1)

Erciyes University Medical School

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (4)

• Turkoglu M, Erdem GU, Suyani E, Sancar ME, Yalcin 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.

  PMID: 23321772 BACKGROUND

• 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.

  PMID: 26521922 BACKGROUND

• 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.

  PMID: 25003980 BACKGROUND

• Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez 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.

  PMID: 26975498 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 28, 2017
• Study Start: November 1, 2016
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)