High Flow Nasal Cannula in Preventing Re-intubation in High-risk COPD Patients
Study Details
Study Description
Brief Summary
Currently, a high flow nasal cannula (HFNC) has been shown to improve extubation outcomes. But, there is a lack of evidence on the utilization of HFNC in high-risk chronic obstructive pulmonary disease (COPD) patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
All COPD patients according to Global Initiative for Obstructive Lung Disease (GOLD) criteria , intubated for 48 h or more, who tolerated a spontaneous breathing trial (SBT) through a T-piece after recovery, but are considered high risk for re-intubation, were eligible for this study.
High risk for re-intubation has been defined as the presence of at least one of the following : age above 65 years old, moderate or severe chronic obstructive pulmonary disease, multiple attempts at weaning before SBT success, and/or prolonged mechanical ventilation for ≥ 7days, heart failure, acute physiology and chronic health evaluation (APACHE II score ≥12), body mass index ≥ 30 kg/m2, or excessive airway secretions.
Patients were observed for 72 hours after extubation. During this time, extubation-related complications, reasons for re-intubation, and time to re-intubation in hours were recorded. All patients were followed up to 60 days from hospital admission. Length of stay in the ICU and hospital and mortality at 60 days were also recorded.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: (High flow nasal cannula (HFNC) This the arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it. |
Device: HFNC versus NIV
Daily screening for weaning readiness by the rapid shallow breathing index (RSBI): the ratio of respiratory frequency to tidal volume (fR/VT), if fR/VT was >105 min-1.L-1, a spontaneous breathing trial was attempted for 30 min with a T-tube on an inspired oxygen fraction (FiO2) of 0.3 to 0.4. Extubation was then ordered by the attending physician.
At extubation, the following variables were recorded: ABGs and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation.Immediately after extubation, eligible patients were randomized to receive either HFNC or NIV respiratory support
|
| Active Comparator: Noninvasive ventilation (NIV) This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it. |
Device: HFNC versus NIV
Daily screening for weaning readiness by the rapid shallow breathing index (RSBI): the ratio of respiratory frequency to tidal volume (fR/VT), if fR/VT was >105 min-1.L-1, a spontaneous breathing trial was attempted for 30 min with a T-tube on an inspired oxygen fraction (FiO2) of 0.3 to 0.4. Extubation was then ordered by the attending physician.
At extubation, the following variables were recorded: ABGs and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation.Immediately after extubation, eligible patients were randomized to receive either HFNC or NIV respiratory support
|
Outcome Measures
Primary Outcome Measures
- the rate of re-intubation among participant [within 72 hours after extubation]
The criteria for immediate re-intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 < 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency > 40/min)
Secondary Outcome Measures
- rate of post-extubation respiratory failure [at 3 days]
Post-extubation respiratory failure definition: presence of any of the following criteria for at least 30 min post-extubation any of the following parameters requiring re-intubation: 1) respiratory acidosis and hypercapnia (arterial pH <7.35 along with an increase in carbon dioxide arterial tension (Pa,CO2) of >20% from the time of extubation), 2) hypoxemia: defined as SpO2 by pulse oximetry <90% or PaO2 <60 mmHg at FiO2 >0.5, 3) decreased level of consciousness, agitation rendering the patient unable to tolerate NIV or HFNC
- Mortality rate [at 60 days]
patient died after reintubation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All intubated COPD patients for 48 h or more, who tolerated a spontaneous breathing trial (SBT) through a T-piece after recovery, but are considered high risk for re-intubation.
-
High risk for re-intubation has been defined as the presence of at least one of the following : age above 65 years old, moderate or severe chronic obstructive pulmonary disease, multiple attempts at weaning before SBT success, and/or prolonged mechanical ventilation for ≥ 7days, heart failure, acute physiology and chronic health evaluation (APACHE II score ≥12), body mass index ≥ 30 kg/m2, or excessive airway secretions
Exclusion Criteria:
-
Patients who were tracheostomies; accidentally extubated or had self-extubation
-
Contraindications to NIV
-
Inability to give informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Doaa Magdy Eid | Assiut | Egypt |
Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: ahmed metwaly, dectorate, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 04355751