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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non invasive ventilation | Active Comparator | 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: -
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| High flow nasal cannula | Experimental | 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: -
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive ventilation | Device | conventional NIV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endotracheal intubation rate. | needs escalation to invasive mechanical ventilation | one week |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital mortality. | death | one week |
| length of hospital stay | hospital coast | one week |
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Inclusion Criteria:
Participants admitted to the RICU with acute hypoxemic respiratory failure requiring NIV support with the following criteria:
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
IX. Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Entsar H mohamed, MD | Contact | +201019968106 | dr.entsar_hsanen@yahoo.com | |
| Gamal M Rabie, professor | Contact | +201155213224 | Gamalagmy135@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed F Adam, lecturer | Assiut University | Principal Investigator |
| Manal A El-Khawaga, lecturer | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University hospital | Recruiting | Asyut | assiut University 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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patients with will be randomly enrolled to either non invasive group or HFNC group and improvement and patient satisfaction will be assessed
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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
| high flow nasal cannula |
| Device |
HFNC ventilation |
|
| duration of ICU stay | icu occupancy | one week |
| duration of intervention | need ventilatory support | one week |
| development of complications | due to devices | one week |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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