HVNI vs NIPPV in Type 2 Respiratory Failure

NCT07065656 | Not Yet Recruiting

• 1 other identifier: SHINE
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if high velocity nasal insufflation (HVNI) is comparable to non-invasive positive pressure ventilation (NIPPV) in treatment of emergency patients with acute respiratory acidosis. In our non-inferiority trial, we hypothesize that HVNI is inferior to NIPPV in reducing PaCO2 in type 2 respiratory failure (T2RF) due to any cause by a pre-specified non-inferiority margin of 4.3% decrease in PaCO2 levels after 30 minutes of treatment. The primary aim is to evaluate if HVNI is non-inferior to NIPPV in reducing PaCO2 levels in patients with T2RF from any cause. Eligible patients will be randomized to HVNI (intervention) or NIPPV (control).

Conditions

Respiratory Failure; Hypoxia; Hypercapnia

Outcome Measures

Primary Outcomes (1)

• Change in PaCO2 levels at 30 and 60 minutes

  Change in PaCO2 levels obtained on ABG results 30 minutes and 60 minutes after start of HVNI or NIPPV \[baseline ABG and ABGs at 30 minutes and 60 minutes will be performed\]

  30 minutes and 60 minutes

Secondary Outcomes (4)

• Change in RR

  30 minutes and 60 minutes

• Change in dypsnea level

  30 minutes and 60 minutes

• Proportion of treatment failure

  Duration of therapy in emergency department, an average of 4 hours

• Adverse events

  Duration of therapy in emergency department, an average of 4 hours

Study Arms (2)

Intervention

EXPERIMENTAL

In the HVNI group, patients will be given oxygen therapy via the Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH) using a small-bore cannula, with a flow rate of up to 45 L/min, starting temperature of 37oC and FiO2 of up to 1.0. Adjustments in flow, temperature and FiO2 will be up to the attending physician's discretion to alleviate respiratory distress and optimize comfort.

Device: Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH)

Control

ACTIVE COMPARATOR

For the NIPPV group, ventilation will be performed with the Respironics Vision V60 (Philips Healthcare, Murrysville, PA) using an oronasal mask of appropriate size, with FiO2 (up to 1.0), inspiratory (IPAP 12 to 20 cmH2O) and expiratory (EPAP 5 to 10 cm H2O) pressures titrated to alleviate patient's respiratory distress.

Device: Respironics Vision V60

Interventions

Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH) DEVICE

Oxygen therapy will be given via the Vapotherm high velocity therapy (HVT) 2.0 (Vapotherm, Inc, Exeter, NH) using a small-bore cannula, with a flow rate of up to 45 L/min, starting temperature of 37oC and FiO2 of up to 1.0.

Intervention

Respironics Vision V60 DEVICE

Ventilation will be performed with the Respironics Vision V60 (Philips Healthcare, Murrysville, PA) using an oronasal mask of appropriate size, with FiO2 (up to 1.0), inspiratory (IPAP 12 to 20 cmH2O) and expiratory (EPAP 5 to 10 cm H2O) pressures titrated to alleviate patient's respiratory distress.

Control

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged 21 years and above, who require NIPPV for T2RF due to any cause in the Emergency Medicine Department of the National University Hospital

You may not qualify if:

• patients with "do-not-resuscitate" orders that include NO non-invasive ventilation use \[patients with max NIV status will still be included\]
• clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes NIPPV or nasal cannula placement
• vulnerable patient populations (e.g., pregnant women, prisoners)
• patients who refused consent
• hemodynamic instability (e.g., hypotension requiring immediate resuscitation), cardiac or respiratory arrest
• patients who require emergency intubation

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Vapotherm, Inc.: collaborator

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia; Hypercapnia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Mui Teng Chua

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07