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Completed

NCT Number: NCT04709562

Clinical Stabilization of Hypercapnia: NIPPV v HVNI

This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation [NIPPV].

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Key information

Conditions

Hypercapnic Respiratory Failure Acid-Base Imbalance Acidosis Acidosis, Respiratory Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Dyspnea Hypercapnic Acidosis Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Presbyterian Hospital, Los Angeles, California, United States

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About this study

The overall objective of this randomized study is to evaluate the efficacy of HVNI, in comparison to NIPPV, to clinically stabilize and provide respiratory therapy to patients who have COPD with moderate-to-severe hypercapnic respiratory distress upon presentation. It is hypothesized that HVNI is comparable to NIPPV in the stabilization and relief of moderate-to-severe hypercapnic respiratory distress upon presentation, by relieving the patient's dyspnea (breathlessness) within 4 hours to a comparable degree to NIPPV.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, 18 years or older with a known or suspected diagnosis of COPD
  • Presentation with acute hypercapnic respiratory failure
  • Moderate to Severe patient baseline hypercarbia/hypercapnia, defined as a baseline PCO2 of 60 mmHg or higher
  • Venous pH of 7.0 - 7.35

Exclusion criteria

  • Severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder)
  • Need for airway protection
  • Primary condition of Congestive Heart Failure
  • Need for emergent intubation
  • Pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia
  • Inability to provide informed consent
  • Pregnancy
  • Known contraindication to perform procedures listed, or therapies described in the protocol
  • Respiratory arrest or significant respiratory depression on presentation
  • Significant nasal occlusion either unilateral or bilateral
  • Absence of spontaneous respiration or known contraindication to HVNI
  • Extreme agitation or uncooperativeness that would hinder either arm of randomized therapy
  • Determined by the clinician to be sufficiently unstable or unsuitable for this study

Treatment and study plan

High Velocity Nasal Insufflation (HVNI)

Device

The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Other names: Vapotherm Precision Flow Plus

Noninvasive Positive Pressure Ventilation (NIPPV)

Device

The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Other names: Philips Respironics V60

Primary outcomes

  1. Rated Perceived Dyspnea [RPD]

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.

Secondary outcomes

  1. Patient Vital Signs - Heart Rate [HR]

    Time frame: During four time points in the study; Baseline, 30 min, 60 min, and 240 min

    Heart rate, measured in beats per minute (bpm)

  2. Patient Vital Signs - Respiratory Rate [RR]

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Respiratory rate, measured in breaths per minute (brpm)

  3. Patient Vital Signs - Oxygen Saturation [SpO2]

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    SpO2 measured as percentage of oxygen saturation (%)

  4. Patient Communication Capability - Patient Stability Index

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Patient stability index, measured by patient's ability to speak in full sentences, rated on a 0-100 scale. Higher scores indicate a better outcome.

  5. Patient Venous Blood Gas - pH

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.

  6. Patient Venous Blood Gas - Venous PCO2

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Partial pressure of CO2 (PCO2), measured in mmHg

  7. Patient Basic Metabolic Panel - Sodium

    Time frame: Baseline, at study start only

    Sodium [Na+], measured in mEq/L

  8. Patient Basic Metabolic Panel - Potassium

    Time frame: Baseline, at study start only

    Potassium [K+], measured in mEq/L

  9. Patient Basic Metabolic Panel - Chloride

    Time frame: Baseline, at study start only

    Chloride [Cl-], measured in mEq/L

  10. Patient Basic Metabolic Panel - Lactate

    Time frame: Baseline, at study start only

    Lactate, measured in mEq/L

  11. Patient Basic Metabolic Panel - Glucose

    Time frame: Baseline, at study start only

    Glucose, measured in mg/dL

  12. Patient Base Excess - Base Excess

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Base Excess, measured in mEq/L

  13. Patient Bicarbonate - Bicarbonate

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Bicarbonate, measured in mEq/L

Other outcomes

  1. Patient Perception Score - Relief of Symptoms

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  2. Patient Perception Score - Comfort/Tolerance

    Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

    Patient's subjective assessment of their comfort and tolerance of therapy during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  3. Clinician Perception Score - Expected/Perceived Outcomes

    Time frame: At study end, 4 hours from study start

    Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  4. Clinician Perception Score - Patient Comfort/Tolerance

    Time frame: At study end, 4 hours from study start

    Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

  5. Clinician Perception Score - Ease of Use

    Time frame: At study end, 4 hours from study start

    Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.

Sponsors and collaborators

Lead sponsor

Vapotherm, Inc.

Industry

Collaborators

  • Dignity Health Medical Foundation
  • Erlanger Baroness Hospital
  • George Washington University
  • Madigan Army Medical Center
  • The Cooper Health System
  • University of Maryland
  • Valley Presbyterian Hospital

Registry information

Official study title

Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure

Acronym: HYPERACT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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