Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

Charité University Medicine Berlin

Status: Terminated

Conditions: Respiratory Distress Syndrome, Newborn; Respiratory Tract Diseases

Treatments: Device: nHFOV; Device: nCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02340299

EA2/011/12

Details and patient eligibility

About

To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).

Full description

Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.

Intervention and treatment protocol as described for the two study arms.

Definition of treatment failure (infant meets at least one criterion):

• Sustained pCO2 >80 mmHg and pH <7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
• Fraction of inspired oxygen (FiO2) >0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
• Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").

Sample size:

Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.

Randomization:

Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.

Data monitoring:

By an independent statistician.

Enrollment: 6 patients

Sex: All

Ages: 5 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age <32+0 weeks
• Birth weight <1500 g
• Received mechanical ventilation via an endotracheal tube for ≥120 h
• Caffeine treatment according to unit guidelines
• paCO2 <65 mmHg with pH >7.2
• FiO2 25-40% to maintain SpO2 at 90-94%.
• Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
• Decision of the attending clinician to extubate

Exclusion criteria

• Major congenital malformation requiring surgery
• Duct-dependent congenital heart disease
• Neuromuscular disease
• Participation in another randomized controlled trial
• Death before reaching the eligibility criteria
• Hydrocortisone treatment at the time of enrolment
• Chronological age >28 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

nHFOV

Experimental group

Description:

Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.

Treatment:

Device: nHFOV

nCPAP

Active Comparator group

Description:

Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician.

Treatment:

Device: nCPAP