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Physiological Changes With High-Flow Nasal Cannula

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ClinicalTrials.gov Identifier: NCT03700606
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

Brief Summary:
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome in Premature Infant Procedure: High flow nasal cannula Procedure: Nasal CPAP Not Applicable

Detailed Description:

After informed consent is obtained, eligible infants who are stable on nCPAP therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled.

All subjects will have physiologic data and electrical impedance tomography collected at:

  1. Baseline nCPAP for 15 minutes
  2. Upon transition to high flow nasal cannula at 8 LPM for 6 hours. Data collection is obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour period
  3. Then upon return to baseline NCPAP for a final 15 minutes of data collection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physiological Changes With High-Flow Nasal Cannula Compared to Nasal CPAP in Extremely Low Birth Weight Infants
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Active Comparator: Nasal CPAP - Period 1
Eligible infants stable on high flow nasal cannula (nCPAP) therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. A data acquisition cart will be placed at the subject's bedside to collect hemodynamic and respiratory parameters measured including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices. A neonatal chest belt, sized to the infant's chest circumference (nipple level) using warmed ultrasound gel applied to the belt beforehand, will collect regional lung volume measurements using electrical impedance tomography (EIT). Subject video recording will capture apnea events and the interventions used to resolve them such as positive pressure ventilation, repositioning, or stimulation. Data will be collected for 15 minutes on nCPAP.
Procedure: Nasal CPAP
Nasal continuous positive airway pressure of 5-7 cm/H20 delivered using Ventilator or bubble cpap device through short nasal prongs or a nasal face mask.

Active Comparator: High Flow Nasal Cannula (HFNC) - Period 2 & 3
Respiratory support will be crossed over to a HFNC Optiflow Jr 2 (Fisher & Paykel Healthcare, Auckland, New Zealand) at a flow rate of 8 LPM. The size of the nasal cannula will be determined according to the manufacturer's instructions in order to maintain a leak at the nares. Identical data collection will occur for two 15 minute periods on HFNC, at the beginning and end of the six hour Study period.
Procedure: High flow nasal cannula
8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.

Active Comparator: Nasal CPAP - Period 4
After 6 hours of HFNC of 8 LPM, or sooner if the infant meets failure criteria, the infant will then be crossed back to the nCPAP device and at the settings previously utilized in Study Period 1. The infant will remain on the nCPAP device with identical data collection for 15 minutes. The total duration of the study and data collection will be 8 hours. The infant's body position will be similar for each lung volume measurement during the study periods.
Procedure: Nasal CPAP
Nasal continuous positive airway pressure of 5-7 cm/H20 delivered using Ventilator or bubble cpap device through short nasal prongs or a nasal face mask.




Primary Outcome Measures :
  1. % Unventilated Lung [ Time Frame: Through study completion, an average of 30 days ]
    Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)


Secondary Outcome Measures :
  1. Geometric Center of Ventilation (CoV) [ Time Frame: Through study completion, an average of 30 days ]
    numeric value that describes the geographic point within the thorax that represents the statistical center of VT

  2. End-expiratory lung volume [ Time Frame: Through study completion, an average of 30 days ]
    % of total VT within 8 lung regions, relative change in uncalibrated aeration



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 23 to 28+6 weeks gestational age at birth
  • Corrected gestational age less than or equal to 30 weeks
  • Over 72 hours of life
  • Stable on Nasal CPAP of 5-7cm H20
  • Hemodynamically stable
  • Tolerating routine handling
  • Nares size appropriate for Fisher & Paykel Optiflow Jr 2 HFNC size XS or small
  • Successfully extubated for 12 hours after administration of surfactant
  • Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg
  • Transcutaneous monitoring in place
  • Stable blood gas (pH>/= 7.25 and PaCO2 <60 mmHg torr)

Exclusion Criteria:

  • Prior pneumothorax or evidence of pulmonary interstitial emphysema.
  • Prior or current pulmonary hemorrhage
  • Congenital airway malformations
  • Major cardiopulmonary malformations
  • Congenital Diaphragmatic hernia or untreated bowel obstruction
  • Poor respiratory drive unresponsive to CPAP therapy
  • Requirement of a nCPAP of >8 cmH20 or FiO2 > 0.3 to maintain oxygen saturations between 90-95 percent.
  • Receiving positive pressure breaths or SIPAP on prongs
  • Conflicting clinical trial
  • Clinically unstable per physician discretion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700606


Contacts
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Contact: Anup Katheria, MD 858-939-4170 anup.katheria@sharp.com
Contact: Felix Ines, RCP-RRT 858-939-4136 felix.ines@sharp.com

Locations
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United States, California
Sharp Mary Birch Hospital for Women & Newborns Recruiting
San Diego, California, United States, 92123
Contact: Anup Katheria, MD    858-939-4170    anup.katheria@sharp.com   
Contact: Felix Ines, RCP-RRT    858-939-4136    felix.ines@sharp.com   
Sponsors and Collaborators
Sharp HealthCare
Investigators
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Principal Investigator: Anup Katheria, MD Sharp HealthCare

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Responsible Party: Anup Katheria, M.D., Director Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT03700606     History of Changes
Other Study ID Numbers: HFNC
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
high flow nasal cannula
nasal cpap
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases