Pilot Study of Physiological Effect of High-Flow Nasal Cannula on Respiratory Pattern and Work of Breathing

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

April 1, 2018

Conditions
COPD
Interventions
OTHER

Esophageal and gastric balloons

Esophageal and gastric pressures will be measured with an esophageal ballon positioned at the lower third of the esophagus, filled with 0.5 mL of air and a gastric balloon filled with 1 mL of air. The proper position of balloons will be verified using the occlusion test as previously described. Transdiaphragmatic pressure (Pdi) is calculated as the difference between gastric (Pga) and esophageal (Pes) pressure. The pressure time integrals of the diaphragm and the other inspiratory muscles are calculated per breath (PTPdi/b and PTPes/b, respectively) and per minute (PTPdi/min and PTPes/min). Measurements will be collected at baseline, at each randomized HFNC and CPAP settings during the last 4 minutes of each 10 minutes session.

OTHER

Respiratory Inductance Plethysmography (RIP) system

Inspiratory tidal volume (VTi), respiratory rate (RR), breath duration (Ttot), inspiratory time (Ti) and fractional inspiratory time (Ti/Ttot) will be determined using a Respiratory Inductive Plethysmography (RIP) system. This will measure the thoracic and abdominal excursion of the subjects via two inductive wires which are sewn into the elastic bands that encircle the thorax and abdomen. The acquired signals represent changes in cross-sectional area and, following calibration to determine the relative contribution of each signal, and volume calibration using spirometry, their weighted sum will reflect VTi. The RIP companion software will be used to derive RR, Ttot, Ti and Ti/Ttot on a breath by breath basis.

OTHER

Sentec transcutaneous monitoring system

The oxygenation, the level of carbon dioxide, and the heart rate will be recorded using the Sentec transcutaneous monitoring system: a probe will be placed at the earlobe or on the forehead, and it will measure in a noninvasive way these parameters.

DEVICE

High-flow humidified nasal oxygen delivery system

DEVICE

CPAP (Positive Control)

Trial Locations (1)

02116

Tufts Medical Center, Boston

All Listed Sponsors
collaborator

Fisher and Paykel Healthcare

INDUSTRY

lead

Tufts Medical Center

OTHER

NCT02514798 - Pilot Study of Physiological Effect of High-Flow Nasal Cannula on Respiratory Pattern and Work of Breathing | Biotech Hunter | Biotech Hunter