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High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

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ClinicalTrials.gov Identifier: NCT04640948
Recruitment Status : Not yet recruiting
First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

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.


Condition or disease Intervention/treatment Phase
Acute Hypercapnic Respiratory Failure Acute Exacerbation of COPD Device: High flow nasal therapy Device: Low flow oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled parallel group trial
Masking: Single (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.
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High flow nasal therapy (HFNT)
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.
Device: High flow nasal therapy
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%.
Other Name: High flow nasal insufflation

Active Comparator: Low flow oxygen (LFO)
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.
Device: Low flow oxygen
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 Measures :
  1. Proportion of patients requiring NIV in each cohort [ Time Frame: 6 hours ]
    Proportion of patients who require NIV by 6 hours of intervention.


Secondary Outcome Measures :
  1. PaCO2 in Kilopascal [ Time Frame: 1 hour, 6 hours and 24 hours. ]
    Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.

  2. PaO2 in Kilopascal [ Time Frame: 1 hour, 6 hours and 24 hours. ]
    Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point.

  3. pH [ Time Frame: 1 hour, 6 hours and 24 hours. ]
    pH measured for acid-base status.

  4. Respiratory rate (Breath/minute) [ Time Frame: At 1 hour, 6 hours and 24 hours. ]
    Rate of breathing per minute as documented in medical notes.

  5. Heart rate (Beat/minute) [ Time Frame: 1 hour, 6 hours and 24 hours. ]
    Heart rate per minute as documented in medical notes.

  6. Mean arterial pressure in millimeters of mercury [ Time Frame: 1 hour, 6 hours and 24 hours. ]
    Mean arterial pressure in millimeters of mercury as documented in medical notes

  7. Intubation rate [ Time Frame: 1 hour, 6 hours and 24 hours. ]
  8. ICU admission [ Time Frame: From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks. ]
  9. 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. ]
  10. 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. ]
  11. 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. ]
  12. Dyspnoea [ Time Frame: 1 hour, 6 hours and 24 hours. ]
    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.

  13. Patient comfort [ Time Frame: 1 hour. ]
    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.



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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:

  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

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): NCT04640948


Contacts
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Contact: Murali Shyamsundar, MD, PhD +44 (0)28 9097 6381 Murali.Shyamsundar@qub.ac.uk
Contact: Asem Alnajada, MSc aalnajada01@qub.ac.uk

Sponsors and Collaborators
Belfast Health and Social Care Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT04640948    
Other Study ID Numbers: 19106MA-AS
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD may be shared on request to the Principal Investigator and will be decided on a case by case basis.

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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
Keywords provided by Belfast Health and Social Care Trust:
Acute exacerbation of COPD
High flow nasal oxygen
High flow nasal insufflation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory