High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure.

Not Applicable

Not yet recruiting

• Conditions: Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure
• Interventions: Device: High flow nasal cannula (HFNC); Device: Non-Invasive Mechanical Ventilation (NIV)

• Registration Number: NCT05499039
• Lead Sponsor: Assiut University

Brief Summary

high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity.

This study aims to evaluate the effectiveness of HFNC compared to NIMV in management of Acute hypoxemic and acute hypercapneic respiratory failure

Detailed Description

* Acute respiratory failure (ARF) is a common and serious complication among hospitalized patients. It is the most frequent reason for admission to the intensive care unit (ICU) . It carries an in-hospital mortality rate of 20.6% and cost 54.3 billion dollars nationwide in United States in 2009. Among those patients with ARF, 42.1 % of patients require mechanical ventilation (MV), which is associated with a significant increase in both length of stay and medical expense

* ARF can be categorized into acute hypoxemic respiratory failure(AHRF) and acute hypercapneic respiratory failure.

* Supplemental oxygen and treatment of the underlying cause is the mainstay of therapy for AHRF. Options for oxygen therapy include conventional oxygen therapy delivered via nasal cannulae (NC) or face masks (FM) initially, followed by non-invasive ventilation (NIV), and finally intubation or mechanical ventilation (MV) .

* Traditional NC and FM (collectively referred to as conventional oxygen therapy or COT) can achieve flow rates of up to 1 5 L/min. However, these flow rates may be significantly lower than patients' spontaneous inspiratory flow rates and the oxygen is diluted as it is mixed with room air Consequently, the fraction of inspired oxygen (FiO2) delivered Is variable and this is thought to explain why many patients require an escalation of oxygen therapy to NIV or MV.

* By contrast, humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity

* HFNC has been well studied in the neonatal and pediatric settings However, in adults, the use of HFNC has Primarily been studied in post-cardiac surgery post-extubation and bronchoscopy patients. However, the utility of HFNC use in adults with AHRF in emergency and general inpatient practice is less clear .Heated and humidified high-flow oxygen through nasal cannula (HFNC) has been developed over the past 2 decades, as an alternative to standard oxygen delivery systems

* . In adults, it has been used to treat hypoxemic respiratory failure, cardiogenic pulmonary edema, postoperatively and postextubation in do-not-intubate patients or during bronchoscopy

* To date, the literature supports the possibility to use HFNC as alternative to non-invasive ventilation (NIV) in some settings, while in others might be even superior . It is also an alternative to standard oxygen as first line therapy in management of patients with acute respiratory failure . NIV is strongly recommended in patients with acute-on-chronic respiratory failure associated with acute respiratory acidosis, the vast majority of whom meet the criteria for Chronic Obstructive Pulmonary Disease (COPD) exacerbation

* Recently, Studies revealed no difference of the 30-day mortality and intubation rate between NIV and HFNC, in severe acute exacerbation of COPD with moderate, hypercapnic, acute respiratory failure. In a retrospective study, that suggeste that HFNC oxygen therapy was beneficial, even in respiratory failure Type 2, resulting in significant improvement of both oxygenation and hypercapnia. another study also indicated that HFNO leads to a flow-dependent reduction in PaCO2 in patients with stable hypercapnic COPD, due to a washout of the respiratory tract and a functional reduction in dead space

* Although cumulative evidence supports that HFNC is effective in patients with hypercapnia, randomized studies to compare HFNC vs. NIV in patients with acute, hypercapnic respiratory failure are missing. so the investigator conducting this prospective, randomized, controlled trial, involving patients admitted to the Emergency Department (ED), to compare the efficacy of HFNC versus NIV in the management of acute hypercapnic respiratory failure.

Study Timeline

• Study First Submitted: 2022-03-07
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Submitted: 2022-08-27
• Last Update Posted: 2022-09-01
• Study Start: 2022-10-10
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age above 18
• Acute hypoxemic respiratory failure. (Participants admitted with acute hypoxemic respiratory with the following criteria:

RR> 25 breath/minute Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.

Hypoxemia evidenced by PaO2 / FiO2 ratio <300)

• Acute hypercapnic respiratory failure ((Participants admitted with acute hypercapneic respiratory with the following criteria:

pO2 less than 60 mm Hg (hypoxemia). pCO2 greater than 50 mm Hg (hypercapnia) with pH less than 7.35. Signs and symptoms of acute respiratory distress)

Exclusion Criteria

• Patients with preprocedural or post-procedural settings (ex: surgery, bronchoscope) post- extubation,
• Patients with cancer or transplant patients,
• Patients less than 18 years old
• Patients with Heart failure patients
• Patients with renal failure patients
• Patients with hemodynamic instability
• Patients with central causes of hypercapnic respiratory failure
• Patients with disturbed conscious level
• Patients who refuse to participate in the study
• Indication for emergency endotracheal intubation
• Tracheotomy or other upper airway disorders
• Active upper gastrointestinal bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A2 (HFNC on hypoxemic)	High flow nasal cannula (HFNC)	Use of HFNC on acute hypoxemic respiratory failure patients
Group B1 (NIVMV on hypercapneic)	Non-Invasive Mechanical Ventilation (NIV)	Use of NIV on acute hypercapneic respiratory failure patients
Group A1 (NIVMV on hypoxemic)	Non-Invasive Mechanical Ventilation (NIV)	Use of NIV on acute hypoxemic respiratory failure patients
Group B2 (HFNC on hypercapneic)	High flow nasal cannula (HFNC)	Use of HFNC on acute hypercapneic respiratory failure patients

Primary Outcome Measures

Name	Time	Method
Evaluation of HFNC and NIV in correction of Acidosis .	Baseline	Evaluation of the effectiveness of HFNC VS NIV in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).; Evaluation of the effectiveness of HFNC in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).
Evaluation of HFNC and NIV in correction of Hypercapnia.	Baseline	Evaluation of the effectiveness of HFNC VS NIV in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)
Evaluation of HFNC and NIV in management of Acute hypoxemic respiratory failure.	Baseline	Evaluation of the effectiveness of HFNC VS NIV in management of Acute hypoxemic respiratory failure through measurement of PO2 via arterial blood gases test (ABG)
Evaluation of HFNC and NIV in correction of Hypoxemia.	Baseline	Evaluation of the effectiveness of HFNC VS NIV in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.
Endotracheal intubation rate.	Baseline	needs escalation to invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
development of complications	one month	due to devices
In hospital mortality.	one month	death
duration of intervention	one month	time needed for ventilatory support
hospital coast	one month	effects on hospital coast
duration of ICU stay .	one month	icu occupancy

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt