search
Back to results

High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure

Primary Purpose

Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
non-invasive ventilation
high flow nasal cannula
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants admitted to the RICU with acute hypoxemic 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 PaO2 / FiO2 ratio <300

Exclusion Criteria:

Patients 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 burn VI. Refusal to participate. VII. Usual long-term treatment with NIV for chronic disease VIII. Altered mental status with decreased consciousness and/or evidence of inability to understand .

IX. Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding

Sites / Locations

  • Assiut University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non invasive ventilation

High flow nasal cannula

Arm Description

Respiratory assistance is provided by a NIV either Puritan Bennet 840 , Engström Carestation or Hamilton-G5 , will be used for conventional non-invasive ventilation via an oronasal mask. Settings will be adjusted based on the clinical assessment of the respiratory therapist . Initial setting includes: - Positive End Expiratory Pressure (PEEP): 5 cmH2O. Pressure support (PS): 12-20 cmH2O. FiO2 will be adjusted to achieve a SpO2 at least 95%

High flow nasal cannula consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers a modified gas flow up to 60 l/ min . will be set with: - Temperature at 37°C or 34°C Flow rate 30: 50 L/min. FiO2 will be adjusted to achieve a SpO2 at least 95%

Outcomes

Primary Outcome Measures

Endotracheal intubation rate.
needs escalation to invasive mechanical ventilation

Secondary Outcome Measures

In hospital mortality.
death
length of hospital stay
hospital coast
duration of ICU stay
icu occupancy
duration of intervention
need ventilatory support
development of complications
due to devices

Full Information

First Posted
December 20, 2018
Last Updated
October 17, 2019
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03788304
Brief Title
High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure
Official Title
High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Since the 90's, non-invasive 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 patient-ventilator asynchrony and even to intubation . High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters\ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% . It is a new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is because, even though NIV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same effect as NIV while being easier tolerated, more physiological , allowing patients to continue to talk, eat and drink through mouth while on HFNC
Detailed Description
Oxygen therapy is the first-line treatment in management of acute respiratory failure (ARF). Different oxygen delivery devices have become available over recent decades, either low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) or high-flow systems (Venturi mask) . The choice of a specific device in management of ARF is based on the severity of hypoxemia, the underlying mechanisms, the patient's breathing pattern and tolerance . Critically ill patients often require high-flow devices to meet their oxygen needs . Tachypneic patients with ARF, have a peak inspiratory flow rate that is usually high and often exceeds the oxygen flow delivered by the traditional oxygen devices . Using conventional devices, oxygen flow is limited to no more than 15 L/min. Meanwhile, the required inspiratory flow for patients with respiratory failure varies widely in a range from 30 to120 L/min. The difference between patient inspiratory flow and delivered flow is large with conventional oxygen devices leading to patient discomfort . Moreover; high respiratory rate can generate significant entrainment of room air in the mask and dilution of the inspired oxygen with an insufficient oxygen concentration. The suboptimal humidification of the inhaled oxygen provided by standard bubble humidifiers and the limited and unknown inspiratory oxygen fraction (FIO2) delivery are additional drawbacks of these devices . 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 patient-ventilator 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 . To ensure good results, an appropriate interface is more important than the ventilation mode . Oronasal masks, nasal masks, and hoods are most commonly used for NIV. Oronasal masks are usually tried first because they ensure the effects of NIV better than other interfaces. Unfortunately, it is not comfortable, and many patients find it hard to tolerate. It is also associated with a relatively high incidence of air leakage. Also, skin lesions at the nose induced by long-term use of this device may result in frequent treatment interruptions and discontinuation. High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% [. HFNO delivery systems: main technical characteristics: - The administration of HFNO requires the following: high pressure sources of oxygen and air, an air-oxygen blender or a high-flow 'Venturi' system (which permits delivery of an accurate FIO2 between 21% and 100%), a humidifying and heating system for conditioning the gas to optimal temperature (37 ºC) and humidity (44mg H2O/ liters), a sterile water reservoir, a non-condensing circuitry, and an interface . The two most widely marketed HFNO systems are the Precision Flow by Vapotherm and Optiflow by Fisher & Pykel Healthcare Ltd. Physiological effects of HFNC: - Gas from an air/oxygen blender that can generate a total flow of up to 60 L/min is heated and humidified with an active humidifier and subsequently delivered through a heated circuit. High flow of adequately heated and humidified gas is considered to have a number of physiological effects Washout of nasopharyngeal dead space: Washout of upper airway dead space from the delivery of a large amount of oxygen can improve the efficiency of ventilation and enhance oxygen delivery . HFNC is the only noninvasive respiratory support that does not increase dead space. With an oxygen mask, especially at low flow, carbon dioxide is rebreathed . Warming and humidification of secretions: Warming of inspired oxygen and heating it to core temperature is more effective at high flow rates (typically >40 L/minute) than low flow rates. Thus, HFNC is better at heating and humidifying inspired oxygen than conventional high-flow systems such as Venturi masks or nonrebreathers (flow rate typically 10 to 15 L/minute) or low-flow systems (flow rates typically <10 L/minute) . Increased humidification results in increased water content in mucous, which can facilitate secretion removal and may also decrease the work of breathing and avoid airway desiccation and epithelial injury Continuous positive airway pressure (CPAP) effect: Several studies in adults have shown that, similar to infants and neonates, HFNC increases nasopharyngeal airway pressure that peaks at the end of expiration (ie, "PEEP effect") . This "PEEP effect" can potentially unload auto-PEEP, decrease work of breathing, and enhance oxygenation in patients with alveolar filling diseases such as congestive heart failure or acute respiratory distress syndrome (ARDS). As flow increases, nasopharyngeal pressure increases (ie, a dose effect) . The CPAP effect is greatest with the mouth closed. In general, every increase of 10 L/minute of flow yields approximately 0.7 cm H2O of airway pressure when the mouth is closed and 0.35 cm of H2O when the mouth is open. Small pliable nasal prongs: HFNC nasal prongs are generally soft and pliable. Consequently, several studies have reported improved patient comfort with HFNC when compared with conventional low-flow oxygen delivered through nasal cannula or high-flow oxygen delivered through a face mask . High flow rates: High flow rates result in minimal entrainment of room air when HFNC is used; this results in more accurate delivery of oxygen. Patients in respiratory distress generate high inspiratory flow rates that exceed flow rates of standard oxygen equipment, resulting in entrainment of room air and a reduction in the delivery of the set FIO2. The rate of flow in HFNC generally exceeds that of the patient, entraining very little room air and resulting in an FIO2 that is more reliably delivered . High flow rates have also been shown to result in an improved breathing pattern by increasing tidal volume and decreasing respiratory rate . Reduction of work of breathing: The HFNO system may significantly reduce the energy requirement (metabolic work) associated with gas conditioning. By providing high gas flows, HFNO reduces the resistance of the upper airway and then decreases the resistive breathing effort .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with will be randomly enrolled to either non invasive group or HFNC group and improvement and patient satisfaction will be assessed
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neither the participant , care provider , the investigator nor the outcome assessor will select patients in both groups , see results of other patients till the end of the study or informed by literature opinion in this intervention
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non invasive ventilation
Arm Type
Active Comparator
Arm Description
Respiratory assistance is provided by a NIV either Puritan Bennet 840 , Engström Carestation or Hamilton-G5 , will be used for conventional non-invasive ventilation via an oronasal mask. Settings will be adjusted based on the clinical assessment of the respiratory therapist . Initial setting includes: - Positive End Expiratory Pressure (PEEP): 5 cmH2O. Pressure support (PS): 12-20 cmH2O. FiO2 will be adjusted to achieve a SpO2 at least 95%
Arm Title
High flow nasal cannula
Arm Type
Experimental
Arm Description
High flow nasal cannula consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers a modified gas flow up to 60 l/ min . will be set with: - Temperature at 37°C or 34°C Flow rate 30: 50 L/min. FiO2 will be adjusted to achieve a SpO2 at least 95%
Intervention Type
Device
Intervention Name(s)
non-invasive ventilation
Intervention Description
conventional NIV
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula
Intervention Description
HFNC ventilation
Primary Outcome Measure Information:
Title
Endotracheal intubation rate.
Description
needs escalation to invasive mechanical ventilation
Time Frame
one week
Secondary Outcome Measure Information:
Title
In hospital mortality.
Description
death
Time Frame
one week
Title
length of hospital stay
Description
hospital coast
Time Frame
one week
Title
duration of ICU stay
Description
icu occupancy
Time Frame
one week
Title
duration of intervention
Description
need ventilatory support
Time Frame
one week
Title
development of complications
Description
due to devices
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants admitted to the RICU with acute hypoxemic respiratory failure requiring NIV support 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 Exclusion Criteria: Patients 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 burn VI. Refusal to participate. VII. Usual long-term treatment with NIV for chronic disease VIII. Altered mental status with decreased consciousness and/or evidence of inability to understand . IX. Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Entsar H mohamed, MD
Phone
+201019968106
Email
dr.entsar_hsanen@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal M Rabie, professor
Phone
+201155213224
Email
Gamalagmy135@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed F Adam, lecturer
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manal A El-Khawaga, lecturer
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
ZIP/Postal Code
assiut University 71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Entsar H mohamed, master
Phone
01019968106
Email
dr.entsar_hsanen@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gamal M Rabie, MD
Phone
01155213224
Email
Gamalagmy135@gmail.com

12. IPD Sharing Statement

Citations:
Citation
1-Renda, T., Corrado, A., Iskandar, G., et al. High-flow nasal oxygen therapy in intensive care and anaesthesia . British journal of anaesthesia 2018 , 120(1), 18-27 2-Kallstrom TJ. AARC clinical practice guideline: oxygen therapy for adults in the acute care facility: 2002 revision and update. Respir Care 2002; 47: 717-20. 3-O'Driscoll BR, Howard LS, Davison AG, on behalf of the British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax 2008; 63: 1-68. 4-Sim MA, Dean P, Kinsella J, et al. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia 2008; 63: 938-40 5-Nishimura, M. High-flow nasal cannula oxygen therapy in adults: physiological benefits, indication, clinical benefits, and adverse effects. Respiratory Care 2016, 61(4), 529-541.
Results Reference
background

Learn more about this trial

High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure

We'll reach out to this number within 24 hrs