Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD

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Brief Title

Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD

Official Title

Effect of Synchronized vs. Continuous High Flow Nasal Cannula Using Neurally Adjusted Ventilatory Assist on Work of Breathing in Infants With Bronchopulmonary Dysplasia

Brief Summary

      Patients will be randomized to begin the study with either NAVA-synchronized or continuous
      HFNC. Each patient will receive two 15-minute trials at different levels of continuous HFNC
      and two 15-minute trials at corresponding levels of synchronized HFNC. In synchronized HFNC,
      using the NIV NAVA mode on the ventilator each subject will receive a constant minimum flow,
      but with each neurally triggered breath (as measured with an Edi catheter), an additional
      flow will be given to the patient. This differs from continuous HFNC in which the subject
      receives a constant flow without variation. Subjects will be observed during the entirety of
      these trials. Values for the primary and secondary outcomes will be monitored, recorded, and
      calculated.
    

Detailed Description

      Prior to the study period each subject will have the following monitoring equipment placed
      (if not already present): Edi catheter, transcutaneous monitor (TCM4, Radiometer, Brea, CA,
      USA) to measure CO2 and O2 levels, pulse oximeter probe (MasimoSET, Irvine, CA, USA) to
      measure oxygen saturations and heart rate, and RIP bands (SleepSense, MFI Medical, San Diego,
      CA, USA) around the chest and abdomen to measure breathing movements and relative tidal
      volume.

      Each subject will be randomized on the day the study is to occur to begin with either
      NAVA-synchronized or continuous HFNC before crossing over to the other mode to serve as
      his/her own control. The same RAM cannula will be used in both study arms and will provide a
      leak of 60-80% as recommended by the product manual. The delivery of high flow during both
      synchronized and continuous HFNC will be given at two commonly provided levels of high flow:
      6 LPM and 8 LPM, given in the same order in each mode (6 LPM then 8 LPM). Each subject will
      receive 15-minute trials of each mode-level combination, for a total of four trials. During
      each trial, the first 10 minutes will be used for stabilization, and the last 5 minutes will
      be used for data collection, as has been done in previous trials. Thus, the mode-level
      combinations of the trials will be as follows: for infants randomized to begin with
      synchronized support: synchronized-6 LPM, synchronized-8 LPM, unsynchronized-6 LPM,
      unsynchronized-8 LPM. For infants randomized to begin with unsynchronized support:
      unsynchronized-6 LPM, unsynchronized-8 LPM, synchronized-6 LPM, unsynchronized-8 LPM.

      The flows described in the NAVA-synchronized trials refer to the peak flow provided during
      inspiration. A baseline flow rate of 2 LPM will be provided expiration in these trials (using
      the PEEP setting corresponding to the appropriate flow rate). During the unsynchronized
      trials, the continuous high flow rate will be provided (as is common practice with the use of
      HFNC). During the NAVA-synchronized HFNC trials, the Edi trigger will be set to 0.5
      microvolts, apnea time to 5 seconds, back up rate to 10 breaths per minute, and backup
      pressure settings will be set to provide an estimated peak flow of 6 or 8 LPM according to
      the designated trial (again, using the pressure setting corresponding to the appropriate flow
      rate).

      During NAVA-synchronized HFNC, the NIV NAVA mode will be set in such a way that synchronized
      HFNC will be provided. A minimal end-expiratory flow of 2 LPM will be provided using the
      positive end expiratory pressure (PEEP) setting in the NIV NAVA mode on the ventilator. The
      PEEP setting corresponding to 2 LPM via the pneumotachograph will be used. In order to
      deliver the desired peak flow rate with each neurally-triggered breath, a NAVA level of 15
      cmH2O/μV will be set, then the maximum pressure setting that corresponds to the desired flow
      rate using the pneumotachograph will be used for the study. The subject will thus be provided
      with "synchronized HFNC". This contrasts with the constant-flow trials when subjects will
      receive a constant and non-synchronized flow using the HFNC software on the ventilator.

      Servo-u ventilators and Servo Tracker Software (Maquet Critical Care, Solna, Sweden) will be
      used in order to track Edi signal. The MP100 Biopac data acquisition (Biopac Systems Inc.,
      Goleta, CA, USA) will be used to collect data from the monitoring devices. HFNC will be
      delivered using appropriately sized RAM cannula to allow for air leak around the subject's
      nares. Persistent bradycardia (less than 100 beats per minutes), desaturation (<85%), or
      hypercarbia (transcutaneous CO2 >70) will result in cessation of the study.
    


Study Type

Interventional


Primary Outcome

Work of breathing

Secondary Outcome

 Thoracoabdominal asynchrony

Condition

Bronchopulmonary Dysplasia

Intervention

Synchronized HFNC

Study Arms / Comparison Groups

 Synchronized HFNC
Description:  This will be the experimental arm in which subjects will receive HFNC synchronized to his/her own efforts via NAVA

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

24

Start Date

February 20, 2020

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Chronological age greater than 28 days

          -  Gestational age at birth less than 32 weeks and 6 days

          -  Diagnosis of BPD (supplemental oxygen requirement for greater than or equal to 28
             days)

          -  Currently receiving noninvasive ventilation support (NIV NAVA, NIPPV, nCPAP, HFNC)

        Exclusion Criteria:

          -  Major congenital anomalies of the heart and lungs

          -  Post menstrual age greater than 50 weeks 0 days

          -  Oxygen requirement greater than 40%
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

, 501-697-1922, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04274192

Organization ID

Synchronized HFNC


Responsible Party

Sponsor

Study Sponsor

Arkansas Children's Hospital Research Institute


Study Sponsor

, , 


Verification Date

July 2020