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

NCT ID: NCT04274192

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-01-28

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

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

Study Groups

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM

Group Type: EXPERIMENTAL

Synchronized HFNC at 6 liters per minute (LPM)

Intervention Type: OTHER

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM

Continuous HFNC at 6 liters per minute (LPM)

Intervention Type: OTHER

Standard HFNC therapy at 6 LPM

Synchronized HFNC at 8 liters per minute (LPM)

Intervention Type: OTHER

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM

Continuous HFNC at 8 liters per minute (LPM)

Intervention Type: OTHER

Standard HFNC therapy at 8 LPM

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous)

Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM. Next, subjects will receive continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.

Group Type: ACTIVE_COMPARATOR

Synchronized HFNC at 6 liters per minute (LPM)

Intervention Type: OTHER

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM

Continuous HFNC at 6 liters per minute (LPM)

Intervention Type: OTHER

Standard HFNC therapy at 6 LPM

Synchronized HFNC at 8 liters per minute (LPM)

Intervention Type: OTHER

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM

Continuous HFNC at 8 liters per minute (LPM)

Intervention Type: OTHER

Standard HFNC therapy at 8 LPM

Interventions

Synchronized HFNC at 6 liters per minute (LPM)

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM

Intervention Type: OTHER

Continuous HFNC at 6 liters per minute (LPM)

Standard HFNC therapy at 6 LPM

Intervention Type: OTHER

Synchronized HFNC at 8 liters per minute (LPM)

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM

Intervention Type: OTHER

Continuous HFNC at 8 liters per minute (LPM)

Standard HFNC therapy at 8 LPM

Intervention Type: OTHER

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%

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherry E Courtney, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

239863

Identifier Type: -

Identifier Source: org_study_id