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High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

Primary Purpose

Acute Hypercapnic Respiratory Failure, Acute Exacerbation of COPD

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High flow nasal therapy
Low flow oxygen
Sponsored by
Belfast Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure focused on measuring Acute exacerbation of COPD, High flow nasal oxygen, High flow nasal insufflation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients > 18 years of age
  2. Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 6 KPa

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnant or Breast-Feeding
  3. Patient cannot read and understand English
  4. Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
  5. Hypercapnia secondary to exacerbation of asthma
  6. Contraindication to NIV
  7. Contraindication to HFNC
  8. Not for escalation to NIV
  9. pH < 7.15
  10. GCS 8 or less
  11. Shock defined as systolic < 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
  12. Respiratory or cardio-respiratory arrest
  13. Any other indication that requires immediate invasive/non-invasive mechanical ventilation

Sites / Locations

  • Mater HospitalRecruiting
  • Royal Victoria HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow nasal therapy (HFNT)

Low flow oxygen (LFO)

Arm Description

Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.

Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.

Outcomes

Primary Outcome Measures

Proportion of patients requiring NIV in each cohort
Proportion of patients who require NIV by 6 hours of intervention.

Secondary Outcome Measures

PaCO2 in Kilopascal
Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.
PaO2 in Kilopascal
Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point.
pH
pH measured for acid-base status.
Respiratory rate (Breath/minute)
Rate of breathing per minute as documented in medical notes.
Heart rate (Beat/minute)
Heart rate per minute as documented in medical notes.
Mean arterial pressure in millimeters of mercury
Mean arterial pressure in millimeters of mercury as documented in medical notes
Intubation rate
ICU admission
In-hospital mortality
ICU length of stay
Hospital length of stay
Dyspnoea
Dyspnoea will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
Patient comfort
Comfort will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.

Full Information

First Posted
September 11, 2020
Last Updated
April 14, 2022
Sponsor
Belfast Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04640948
Brief Title
High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure
Official Title
High Flow Nasal Cannula Therapy for Initial Oxygen Administration in Acute Hypercapnic Respiratory Failure - A Comparison Study of Two Current Standards of Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belfast Health and Social Care Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic lung conditions such as smoking related lung damage lead to breathing fail. This results in accumulation of gases such as carbon-di-oxide in the body especially during periods of illness known as exacerbation. Current management of carbon-di-oxide accumulation is administration of oxygen, nebulisers, antibiotics etc and if necessary, provide a tight fitting mask around the face to provide breathing support. If this fails, then a patient is placed on a mechanical ventilator. The tight fitting mask therapy is also called non-invasive ventilation and is used widely but patients acceptability of the therapy is limited. Providing a high flow of air with some oxygen could potentially provide the same benefit of the non-invasive ventilation and may also be better accepted by patients. Currently the knowledge and evidence from studies suggest a beneficial role for this high flow therapy but this has not been investigated in well designed studies. In the proposed study we aim to investigate whether use of the high flow therapy reduces the need for non-invasive ventilation in patients who present with a recent onset accumulation of carbon-di-oxide in their body due to long-term lung disease. If this shows benefit, it will lead to a bigger trial with patient benefiting by reduction in the non-invasive ventilation or indeed a need for an invasive breathing machine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypercapnic Respiratory Failure, Acute Exacerbation of COPD
Keywords
Acute exacerbation of COPD, High flow nasal oxygen, High flow nasal insufflation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled parallel group trial
Masking
Outcomes Assessor
Masking Description
Due to the nature of the intervention, the participants , care provider and investigator cannot be blinded but the outcome is objective and data will be analyzed by statistician independent of the study team.
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High flow nasal therapy (HFNT)
Arm Type
Experimental
Arm Description
Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.
Arm Title
Low flow oxygen (LFO)
Arm Type
Active Comparator
Arm Description
Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.
Intervention Type
Device
Intervention Name(s)
High flow nasal therapy
Other Intervention Name(s)
High flow nasal insufflation
Intervention Description
Controlled oxygen administration using at least 20 L/min of flow rate and titrated up as tolerated. Titration of supplemental oxygen to an arterial saturation between 88 - 92%.
Intervention Type
Device
Intervention Name(s)
Low flow oxygen
Intervention Description
Controlled oxygen administration using (venturi mask or nasal cannulae) titrated to an arterial saturation between 88 - 92% as the initial oxygen administration method with a flow rate of <20 L/min.
Primary Outcome Measure Information:
Title
Proportion of patients requiring NIV in each cohort
Description
Proportion of patients who require NIV by 6 hours of intervention.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
PaCO2 in Kilopascal
Description
Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.
Time Frame
1 hour, 6 hours and 24 hours.
Title
PaO2 in Kilopascal
Description
Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point.
Time Frame
1 hour, 6 hours and 24 hours.
Title
pH
Description
pH measured for acid-base status.
Time Frame
1 hour, 6 hours and 24 hours.
Title
Respiratory rate (Breath/minute)
Description
Rate of breathing per minute as documented in medical notes.
Time Frame
At 1 hour, 6 hours and 24 hours.
Title
Heart rate (Beat/minute)
Description
Heart rate per minute as documented in medical notes.
Time Frame
1 hour, 6 hours and 24 hours.
Title
Mean arterial pressure in millimeters of mercury
Description
Mean arterial pressure in millimeters of mercury as documented in medical notes
Time Frame
1 hour, 6 hours and 24 hours.
Title
Intubation rate
Time Frame
1 hour, 6 hours and 24 hours.
Title
ICU admission
Time Frame
From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
Title
In-hospital mortality
Time Frame
From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.
Title
ICU length of stay
Time Frame
From the date of ICU admission until the date of last documented ICU discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
Title
Hospital length of stay
Time Frame
From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
Title
Dyspnoea
Description
Dyspnoea will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
Time Frame
1 hour, 6 hours and 24 hours.
Title
Patient comfort
Description
Comfort will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
Time Frame
1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients > 18 years of age Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 6 KPa Exclusion Criteria: Age < 18 years Pregnant or Breast-Feeding Patient cannot read and understand English Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology Hypercapnia secondary to exacerbation of asthma Contraindication to NIV Contraindication to HFNC Not for escalation to NIV pH < 7.15 GCS 8 or less Shock defined as systolic < 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation Respiratory or cardio-respiratory arrest Any other indication that requires immediate invasive/non-invasive mechanical ventilation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murali Shyamsundar, MD, PhD
Phone
+44 (0)28 9097 6381
Email
Murali.Shyamsundar@qub.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Asem Alnajada, MSc
Email
aalnajada01@qub.ac.uk
Facility Information:
Facility Name
Mater Hospital
City
Belfast
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD may be shared on request to the Principal Investigator and will be decided on a case by case basis.
Citations:
PubMed Identifier
33419742
Citation
Alnajada A, Blackwood B, Mobrad A, Akhtar A, Shyamsundar M. High-flow nasal cannula therapy for initial oxygen administration in acute hypercapnic respiratory failure: study protocol of randomised controlled unblinded trial. BMJ Open Respir Res. 2021 Jan;8(1):e000853. doi: 10.1136/bmjresp-2020-000853.
Results Reference
derived

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High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

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