Clinical trial NCT04998383: HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Official title: HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comparison Between HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either high-velocity nasal insufflation or noninvasive positive-pressure ventilation therapy and they will be enrolled if they met the inclusion criteria.
Primary purpose: TREATMENT

Brief summary: 1. To study the efficacy and safety of high flow nasal oxygenation using high velocity nasal insfflation technique(HiVNI) in comarison with non invasive positive pressure ventilation in COPD patients with acute hyercapnic respiratory failure
2. To do selection criteria for the indication of this new physiological technique in critically ill COPD patients

Detailed description: Dyspnea and acute respiratory failure are among the top 5 reasons for patients to present to the emergency department (ED)(1).Supplemental oxygen therapy forms the cornerstone of resuscitation of the acutely unwell patient.Under normal circumstances, tissue hypoxia occurs within 4 min of inadequate tissue oxygenation (2). Oxygen delivery to the peripheral tissues depends upon the product of cardiac output and the arterial oxygen content (3), which is partly dependent on FIO2. In intensive care unit (ICU) patients with acute respiratory failure, non-invasive strategies of oxygenation are mainly used to avoid invasive mechanical ventilation (4). In such situations, the goal of treatment should not only be survival, but also improved respiratory condition and avoidance of inappropriate discomforts. Since the 90's, noninvasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patientventilator asynchrony and even to intubation. It may have other deleterious effects such as delayed intubation by masking signs of respiratory distress, or barotrauma by the high tidal volume potentially generated under positive pressure (5). High-velocity nasal insufflation (Hi-VNI), a viable alternative to NiPPV in treating adults in undifferentiated respiratory distress. It provides both oxygenation and ventilatory support to reduce hypercapnia(6).It focuses on optimum efficiency of the deadspace purge to augment ventilation (7,8), in addition to delivering up to 100% oxygen by nasal cannula(9,10) This is accomplished by use of small-bore nasal cannulae (typically 2.7-mm internal diameter for adult patients) to produce high velocity flow that is approximately 360% greater than that of the larger bore cannulae. It requires a flow of 25 to 35 L/min in adults to accomplish a complete purge of the extrathoracic anatomic reservoir between breaths (8,11).

Eligibility criteria: Inclusion Criteria:Participants admitted to the RICU with acute hypercapnic respiratory failure requiring NIV support with the following criteria:

1. RR\> 25 breath/minute.
2. Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
3. Hypoxemia evidenced by the following items:

   * In patient with hypercapnic ARF:

I.Need for oxygen therapy at FIO2\> 40% to maintain PaO2 \> 60 mmHg or SaO2\> 90% II.Blood gas analysis shows pH \<7.35 and paCO2\> 45 mmHg

-

Exclusion Criteria:Patients with ARF who have any of the following:

I.Indication for emergency endotracheal intubation. II.HR \< 50 beat\\minute with decreased level of consciousness III.Persistent hemodynamic instability with

* Systolic blood pressure \<90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg.
* life-threatening arrhythmia. IV.Undrained pneumothorax or Pneumothorax with persistent air leak. V.Extensive facial trauma or burnVI.Refusal to participate. VII.Usual long-term treatment with NIV for chronic disease

Primary outcomes:
measure: Endotracheal intubation rate
timeFrame: after 2 Hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed hamed, prof.dr
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Khalid Hussein, prof.dr
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Samiaa Hamdy, assistant professor
role: STUDY_DIRECTOR
References:
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citation: Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.