Recruiting

Non-invasive Ventilation

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT02051491

Conditions

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

BP-NCPAP

NIHFV

Study Details

Brief summary:

In preterm infants, endotracheal mechanical ventilation is well known to cause various forms of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and require intubation. A relatively recent mode of NIV is non-invasive high frequency ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be ventilated effectively. However, its efficacy in comparison with other existing modes of NIV remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in preterm infants in preventing intubation following NCPAP failure.

Conditions

Respiratory Failure

Study ID

NCT02051491

Start date

Jun, 2013

Status verified date

May, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Nov, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Greater than 72 hours post-natal age AND currently on NCPAP
  • Less than 1,250 g when on NCPAP at time of enrollment

Exclusion Criteria:

  • Congenital or acquired abnormality of upper airways
  • Severe congenital anomalies including cyanotic congenital heart disease
  • Severe nasal excoriation/injury preventing use of NIV interface
  • Greater than 2,000 grams at time of randomization

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BP-NCPAP

Nasal BP-NCPAP will be delivered using the Infant Flow® SiPAP™ and either nasal prongs or mask interface. A blood gas (arterial if an arterial line exists, or a capillary sample) will be drawn at the time of NCPAP failure (time 0) unless one was done within 1 hour preceding the randomization. The blood gas will then be repeated at 1 hour and recorded along with transcutaneous carbon dioxide (TcCO2) monitor data (if available). Initial settings of BP-NCPAP will be a lower level PEEP of 5 cm water (H2O) and a higher level PEEP of 8 cm H2O at a cycle rate of 20 per minute with 1 second at the higher PEEP per cycle. The settings can then be adjusted and titrated up to a maximum of 7 and 10 cm H2O for the lower and higher PEEPs respectively at a maximum rate of 30 cycles per second based on fraction of inspired oxygen (FiO2) requirements.

experimental: NIHFV

NIHFV will be provided using the Drager VN500, using either nasal prong or mask interfaces.A blood gas (arterial if an arterial line exists, or a capillary sample) will be drawn at the time of NCPAP failure (time 0) unless one was done within 1 hour preceding the randomization. The blood gas will then be repeated at 1 hour and recorded along with TcCO2 monitor data (if available). Initial settings for NIHFV arm will be MAP of 8 cm H2O, frequency of 10 Hz, and amplitude of 20 cm H2O. The maximum allowable MAP will be 10 cm of H2O. The range of frequency allowed will be 6 - 14 Hz. Both frequency and amplitude will be adjusted to try and achieve palpable/visible chest movement and to achieve target CO2 levels for the particular patient.

Interventions

BP-NCPAP

Initial settings of BP-NCPAP will be a lower level PEEP of 5 cm H2O and a higher level PEEP of 8 cm H2O at a cycle rate of 20 per minute with 1 second at the higher PEEP per cycle. The settings can then be adjusted and titrated up to a maximum of 7 and 10 cm H2O for the lower and higher PEEPs respectively at a maximum rate of 30 cycles per second based on FiO2 requirements.

NIHFV

The initial settings will be a MAP of 8 cm H2O, frequency of 10 Hz, and amplitude of 20 cm H2O. The maximum allowable MAP will be 10 cm of H2O. The range of frequency allowed will be 6 - 14 Hz. Both frequency and amplitude will be adjusted to try and achieve palpable/visible chest movement and to achieve target CO2 levels for the particular patient.

Primary outcome measure

  • Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Vibhuti Shah, MD

1-416-586-4816vshah@mtsinai.on.ca

Amit Mukerji, MD

416-320-7716amit.mukerji@utoronto.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Vibhuti Shah, MD, FRCPC

416-586-4816vshah@mtsinai.on.ca

Principal Investigator:

Vibhuti Shah, Md, FRCPC

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

May 16, 2014

Last verified

May, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2014-05-16.