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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 (NIVMV on hypoxemic) | Active Comparator | Use of NIV on acute hypoxemic respiratory failure patients |
|
| Group A2 (HFNC on hypoxemic) | Experimental | Use of HFNC on acute hypoxemic respiratory failure patients |
|
| Group B1 (NIVMV on hypercapneic) | Active Comparator | Use of NIV on acute hypercapneic respiratory failure patients |
|
| Group B2 (HFNC on hypercapneic) | Experimental | Use of HFNC on acute hypercapneic respiratory failure patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal cannula (HFNC) | Device | 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% |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of HFNC and NIV in correction of Acidosis . | 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). | Baseline |
| Evaluation of HFNC and NIV in correction of Hypercapnia. | Evaluation of the effectiveness of HFNC VS NIV in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG) | Baseline |
| Evaluation of HFNC and NIV in management of Acute hypoxemic respiratory failure. | 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) | Baseline |
| Evaluation of HFNC and NIV in correction of Hypoxemia. | Evaluation of the effectiveness of HFNC VS NIV in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter. | Baseline |
| Endotracheal intubation rate. | needs escalation to invasive mechanical ventilation | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital mortality. | death | one month |
| duration of intervention | time needed for ventilatory support | one month |
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Inclusion Criteria:
RR> 25 breath/minute Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
Hypoxemia evidenced by PaO2 / FiO2 ratio <300)
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelrahman Mo Alham, Demonstrator | Contact | 01014546379 | abdoverno@gmail.com | |
| Peter At Rizk | Contact | 01553529181 |
| Name | Affiliation | Role |
|---|---|---|
| Zein Al-abdeen Ah Sayed, professor | Assiut University | Study Director |
| Taghred SA Meshref, professor | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | Egypt |
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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
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| Non-Invasive Mechanical Ventilation (NIV) | Device | 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% Intervention: Device: non-invasive ventilation |
|
| hospital coast | effects on hospital coast | one month |
| duration of ICU stay . | icu occupancy | one month |
| development of complications | due to devices | one month |
| 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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