Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants
- Conditions
- Extubation FailurePrematurity
- Interventions
- Device: Heated Humidified High-Flow Nasal Cannula
- Registration Number
- NCT02887846
- Lead Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Brief Summary
Purpose is to show that HHHFNC method is as effective and safe as nCPAPand even more comfortable than it as non-invasive respiratory support for the prevention of extubation failure in preterm with gestational age of 26-32 weeks.
Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study.When patients were Fi O2 \< 0,40, Pa CO2 \< 65 mmHg, pH\> 7.20, MAP (mean airway pressure) \<7 cm H2O, they will be extubated if statistically stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is\<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 \< 0.30 at 24 hours and above, free oxygen will be introduced.
- Detailed Description
Purpose is to show that HHHFNC method is as effective and safe as nCPAP and even more comfortable than it as non-invasive respiratory support for the prevention of extubation failure in preterm with gestational age of 26-32 weeks.
Method
Primary Outcome Measures:
The effectiveness of HHHFNC and nCPAP techniques for the prevention of extubation failure within 7 days following the first extubation in preterms in need of mechanical ventilation within the first 7 postnatal days
Secondary Outcome Measures:
* the total duration of invasive and non-invasive respiratory support and the duration of free oxygen demand of patients
* Premature morbidities such as PDA, NEC, ROP, IVH, BPDand sepsis
* The degree of nasal trauma score and the degree of nasal mucosal injury
* FiO2 levels first before extubation and 6 hours after extubation
* The causes of reintubation such as apnea, acidosis, and increased need of FiO2
* The reintubation predisposing factors such as pneumothorax, atelectasis, PDA after extubation
* The weight change in the first 7-day period after extubation
* The two groups in terms of neurodevelopmental changes
Study design Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study. When patients were Fi O2 \< 0,40, Pa CO2 \< 65 mmHg, pH\> 7.20, MAP (mean airway pressure) \<7 cm H2O, they will be extubated if statistically stable. Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is\<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 \< 0.30 at 24 hours and above, free oxygen will be introduced.
Reintubation criteria is set as;
* FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
* Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
* Persistent acidosis; presence of pH \< 7.20 and PCO2 \> 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
* Severe respiratory distress,
* Pulmonary haemorrhage and cardiopulmonary arrest.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Preterm infants with gestational age between 26 weeks 0 days and 31 weeks 6 days will be included.
1- Presence of major congenital anomaly, 2- Presence of neuromuscular disease, 3- Need of surgery within 7 days following the extubation 4- Consent not provided or refused
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1 Heated Humidified High-Flow Nasal Cannula Heated humidified high-flow nasal cannula therapy device for post extubation group 2 Heated Humidified High-Flow Nasal Cannula Nasal continuous positive airway pressure for post extubation
- Primary Outcome Measures
Name Time Method extubation failure 7 day The effectiveness of HHHFNC and nCPAP techniques for the prevention of extubation failure within 7 days following the first extubation in preterms in need of mechanical ventilation within the first 7 postnatal days
- Secondary Outcome Measures
Name Time Method