Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure

Hypercapnic Respiratory Failure Clinical Trial

Official title:

Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05497986
• Other study ID #: Verdun2022_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2022
• Source: Hôpital de Verdun
• Contact: Ivan Pavlov, M.D
• Phone: 514-362-1000
• Email: ivan.pavlov.md[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current evidence suggests a mechanistic and physiological rationale for the use of high flow nasal cannula (HFNC) in acute respiratory hypoxemic failure (AHRF) based on physiological studies in airway models, healthy volunteers and patients with Chronic Obstructive Respiratory Disease (COPD). This is supported by observational studies in patients with AHRF with reductions in a range of respiratory and other physiological parameters. Observational studies also suggest similar intubation rates and lower failure rates with HFNC when compared to non-invasive ventilation (NIV) with improved patient acceptance and tolerance for HFNC. The role of HFNC is less clear in acute hypercapnic respiratory failure. Although non-invasive ventilation is the recommended treatment, it is associated with discomfort, and a significant proportion (up to 25% in some reports) cannot tolerate non-invasive ventilation. Observational reports and limited data from randomized controlled trials suggests that HFNC is effective in treating patients with hypercapnic respiratory failure. We designed this trial to assess whether early application of HFNC in patients with non-severe hypercapnic respiratory failure can correct barometric abnormalities, and prevent progression to non-invasive ventilation or tracheal intubation and mechanical ventilation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients > 18 years of age
• Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 45 mmHg

Exclusion Criteria:

• Pregnant or Breast-Feeding
• Patients who cannot read and understand French or 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 based on a ceiling of care
• 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

Related Conditions & MeSH terms

• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• High flow nasal cannula
HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.
• Conventional low flow oxygenation
Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.

Locations

Country	Name	City	State
Canada	CISSS-de-la-Montérégie-Centre	Longueuil	Quebec
Canada	CIUSSS de l'Est-de-l'ïle-de-Montréal	Montréal	Quebec
Canada	Hôpital de Verdun	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital de Verdun

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients progressing to NIV in each cohort		6 hours
Secondary	Venous blood gas PCO2		1 hour, 6 hours, and 24 hours
Secondary	Venous blood gas pH		1 hour, 6 hours, and 24 hours
Secondary	Respiratory rate	Number of breaths per minute, as documented in the medical chart	1 hour, 6 hours, 24 hours, and daily until study completion
Secondary	Heart rate	Number of heart beats per minute, as documented in the medical chart	1 hour, 6 hours, 24 hours, and daily until study completion
Secondary	Mean arterial pressure	Mean arterial pressure, as documented in the medical chart	1 hour, 6 hours, 24 hours, and daily until study completion
Secondary	Incidence of intubation		Up to 90 days after enrolment, or until hospital discharge
Secondary	Admission to the intensive care unit		Up to 90 days after enrolment, or until hospital discharge
Secondary	In-hospital mortality		Up to 90 days after enrolment, or until hospital discharge
Secondary	Intensive care unit length of stay		Up to 90 days after enrolment, or until discharge from the intensive care unit
Secondary	Hospital length of stay		Up to 90 days after enrolment, or until hospital discharge
Secondary	Patient comfort	Level of comfort assessed on a visual analogue scale by the patient	1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Secondary	Shortness of breath	Severity of the shortness of breath assessed on a visual analogue scale by the patient	1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days