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Acute hypercapnic respiratory failure (AHRF), which is commonly defined as arterial partial pressure of carbon dioxide (PaCO2) ≥ 45 mmHg and frequently accompanied by reduced levels of arterial partial pressure of oxygen (PaO2), can occur in a variety of etiologies, mainly in chronic respiratory diseases, such as exacerbation of chronic obstructive pulmonary disease, cystic fibrosis, thoracic deformities, as well as other conditions, such as neuromuscular disease The purpose of this research is to To compare efficacy of administration of high flow nasal canula versus non-invasive mechanical ventilation on preventing reintubation during 72 hours postextubation of patients with type 2 respiratory failure with difficult weaning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow nasal canula (HFNC) group. | Active Comparator |
| |
| Non-invasive positive pressure mechanical ventilation (NIPPV) group. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal canula | Device | All patients assigned to the HFNC group will receive HFNC immediately after extubation. Researchers will need to choose the suitable size nasal catheter. The initial airflow will be set to 50 L/min and adjusted according to patient tolerance with an absolute humidity setting to 44 mgH2O/L and the temperature setting to 37 °C.The patient's respiratory rate will be maintained below 30 beats/min or the baseline level before extubation with a SpO2 at 88-92%. HFNC failure is defined as escalation to NIV or invasive mechanical ventilation due to respiratory failure. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcomes of this study will be the rate of re- intubation | frequency of re-intubation | 72 hours and 7 days after extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| ventilator-free days | ventilator-free days at 28 days post-randomization | 28 days post-randomization |
| duration of respiratory support after extubation. | duration of respiratory support after extubation |
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Inclusion Criteria:
Hypercapnic respiratory failure is defined as an elevation in PaCO2 greater than 45 mmHg and a pH lower than 7.35 resulting from respiratory pump failure and/or production.
Type 2 respiratory failure common causes :
Exclusion Criteria:
1. Lack of informed consent. 2. A contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, hemodynamic instability, recent esophageal surgery).
3. Patients with poor short-term prognosis (very high risk of death within seven days or receiving palliative care).
4. Other organs' failure e.g severe heart, brain, liver, or kidney failure. 5. Tracheostomised patients. 6. Loss of follow up and uncertain 28 day survival.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Mostafa Abdelhamid, Professor of Anesthesia | faculty of medicine, Benha university | Study Director |
| Fatma Ahmed Abdelfattah, MD Anesthesia and intensive ca | faculty of medicine, Benha university | Principal Investigator |
| Mohamed Shaker Sadek, MD chest diseases | faculty of medicine, Benha university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banha Faculity of Medicine | Banhā | Elqalyoubea | 13511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21765357 | Background | Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a. | |
| 30636373 | Background | Comellini V, Pacilli AMG, Nava S. Benefits of non-invasive ventilation in acute hypercapnic respiratory failure. Respirology. 2019 Apr;24(4):308-317. doi: 10.1111/resp.13469. Epub 2019 Jan 12. |
| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Arnaud W Thille et al | Clinical Study Report | View IPD |
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To apply postextubation NIV or HFNC to prevent reintubation
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| Non-invasive positive pressure mechanical ventilation | Device | All patients assigned to the control group will receive NIV immediately after extubation. Researchers will use a standard oronasal mask to connect the patient to the ventilator. The patients will be on Spontaneous/Timed (S/T) mode, with the initial end-expiratory pressure setting to 4 cmH2O. The pressure level will gradually increase to ensure that the patients can trigger the ventilator with each inhalation. The initial inspiratory pressure will be set at 8 cmH2O and adjusted according to the tidal volume with 6-8 ml/kg and tolerance of patients. The pres- sure level and the fraction of inspiration oxygen will be adjusted in order to maintain the respiratory rate ≤ 30/ min or the baseline level before extubation, a partial pressure of carbon dioxide (PaCO2) at 45-60 mmHg or the last PaCO2 level recorded before extubation, and a pulse oxygen saturation at 88-92%. NIV treatment failure is defined as a return to invasive mechanical ventilation. |
|
| 72 hours after extubation |
| treatment failure and reintubation rate | treatment failure rate (including reintubation rate and replacement of respiratory support: for patients in the HFNC group, treatment failure means to upgrade to NIV or invasive mechanical ventilation; for patients in the NIV group, treatment failure means to change to invasive mechanical ventilation). | during 48 hours after extubation. |
| respiratory support related adverse events | respiratory support related adverse events | 72 hours post extubation |
| Delirium | the incidence of delirium using RAAS (Richmond Agitation-sedation score) | 72 hours postextubation |
| Related Info | View source |
Extubation failure is associated with a poor prognosis, but the respective roles for reintubation per se and underlying disease severity remain unclear. Our objectives were to evaluate the impact of failed extubation, whether planned or unplanned, on patient outcomes and to identify a patient subset at risk for extubation failure. |