Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

NCT02340299 | Terminated Results DMC

• 1 other identifier: EA2/011/12
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Tract Diseases

Keywords

High Frequency Oscillation Ventilation; Nasal Continuous Positive Airway Pressure; Airway Extubation; Prematurity

Outcome Measures

Primary Outcomes (1)

• paCO2 at 72 h After Extubation

  Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.

  64 h to 80 h

Secondary Outcomes (13)

• pH at 2 h After Extubation

  within the first 6 h after extubation

• paO2 at 2 h After Extubation

  within the first 6 h after extubation

• paCO2 at 2 h After Extubation

  within the first 6 h after extubation

• Base Excess at 2 h After Extubation

  within the first 6 h after extubation

• pH at 72 h After Extubation

  64-80 h after extubation

Other Outcomes (5)

• pH at 2 h After Switch to "Rescue Treatment"

  within the first 6 h after switch to "rescue treatment"

• paO2 at 2 h After Switch to "Rescue Treatment"

  within the first 6 h after switch to "rescue treatment"

• paCO2 at 2 h After Switch to "Rescue Treatment"

  within the first 6 h after switch to "rescue treatment"

Study Arms (2)

nHFOV

EXPERIMENTAL

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.

Device: nHFOV

nCPAP

ACTIVE COMPARATOR

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.

Device: nCPAP

Interventions

nHFOV DEVICE

Extubation to ventilator-derived nHFOV using binasal prongs

nHFOV

nCPAP DEVICE

Extubation to ventilator-derived nCPAP using binasal prongs

nCPAP

Eligibility Criteria

• Age: 5 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Dpt. of Neonatology, Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 31023363 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Tract Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: PD Dr. Christoph Czernik, principal investigator
• Organization: Charité - Universitätsmedizin Berlin

christoph.czernik@charite.de

+49 30 450

Study Officials

• Christoph Czernik, MD PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 10, 2015
• First Posted: January 16, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 5, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-07

Locations

DE (1)