Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients

January 24, 2017 updated by: Miguel R. Goncalves, Hospital Sao Joao

Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial

The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and 90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.

Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide, Heliox 28 and oxygen.

Conventional oxygen supplementation is often used in these patients, but it may be inadequate, especially if they require high flows (from 30L/min to 120L/min in acute respiratory failure).

High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which generates the gas flow rate up to 55 L/min and a heated humidification system. This technology may have an important role in reducing respiratory distress in do-not-intubate patients.

Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration; a better matching between patient's inspiratory demand and oxygen flow; generation of a certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure and recruitment; improvement of lung and airway mucociliary clearance due to the heated and humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and speech.

The investigators hypothesize that patients supported with HFONC need less opioids to decrease dyspnoea.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-319
        • University Hospital of São João

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis, COPD, …) - (McCabe score > 3 [<6 months life expectancy] and a Palliative Prognostic Index score ≥ 4) admitted to hospital because of acute respiratory failure and distress
  • Had chosen to forego all life support and receiving only palliative care
  • Severe hypoxemia (PaO2/FiO2< 250)
  • At least one of the following: dyspnoea (Borg scale ≥4), signs of respiratory distress, and respiratory rate greater than 30 beats per min

Exclusion Criteria:

  • Patients had to be competent (Kelly score <4)
  • Refusal of treatment
  • Weak cough reflex
  • Agitation or non-cooperation
  • Uncontrolled cardiac ischemia or arrhythmias
  • Failure of more than two organs
  • Use of opioids within the past 2 weeks
  • Adverse reactions to opioids
  • History of substance misuse
  • Known contraindication for morphine (acute renal failure and recent head injury)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFONC
Patient will use HFONC with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%.
Device: HFONC
Other Names:
  • Optiflow (Fisher&Paykel ™)
Other: Conventional oxygen
Patient will use venturi or reservoir mask with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%.
Device: Conventional oxygen therapy
Other Names:
  • Venturi mask
  • Reservoir mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnoea
Time Frame: 2 days
We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
2 days
Opioids
Time Frame: 2 days
By randomizing the two groups we will be able to compare the total use of opioids.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiologic variables
Time Frame: 2 days
The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.
2 days
Patient comfort
Time Frame: 2 days
Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.
2 days
Mortality
Time Frame: 6 months
Overall mortality in hospital and at 3 months and 6 months after discharge.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Joao

Investigators

  • Principal Investigator: Miguel R Gonçalves, PhD, Pulmonology Department, University Hospital São João

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 28, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PalliativeHFONC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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