Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

NCT ID: NCT02340299

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-12-31

Brief Summary

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).

Detailed 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.

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Tract Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nHFOV

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.

Group Type: EXPERIMENTAL

nHFOV

Intervention Type: DEVICE

Extubation to ventilator-derived nHFOV using binasal prongs

nCPAP

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.

Group Type: ACTIVE_COMPARATOR

nCPAP

Intervention Type: DEVICE

Extubation to ventilator-derived nCPAP using binasal prongs

Interventions

nHFOV

Extubation to ventilator-derived nHFOV using binasal prongs

Intervention Type: DEVICE

nCPAP

Extubation to ventilator-derived nCPAP using binasal prongs

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Christoph Czernik

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Czernik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Dpt. of Neonatology, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

Fischer HS, Buhrer C, Czernik C. Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial. BMC Res Notes. 2019 Apr 25;12(1):237. doi: 10.1186/s13104-019-4268-2.

Reference Type: DERIVED

PMID: 31023363 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EA2/011/12

Identifier Type: -

Identifier Source: org_study_id