The Role of Circuit Flow During Mechanical Ventilation of Neonates

Summary

During neonatal mechanical ventilation inflating pressures, tidal volumes, and inflation and expiration times need to be set and adjusted to optimise oxygenation and carbon dioxide removal. The flow of gas into the ventilator circuit has a big effect on ventilation but is usually set to a constant value (\~8 L/min) for all babies regardless of size or severity of illness, based on minimal research. High circuit flow may lead to lung damage and low flow to inadequate ventilation. The investigators recently developed a unique system to capture, record, analyse, and display ventilator data at high resolution over long periods. Using this the investigators will investigate, in within patient cross-over studies, how the level of gas flow affects ventilator parameters and ventilation, in two commonly used ventilation modes. The results will determine the lowest circuit flow that ventilates a baby safely and effectively. It will also provide preliminary data for a randomised trial.

Conditions

• Respiratory Distress Syndrome in Premature Infant

Interventions

DEVICE

SIPPV_VG_0_08

Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.08 seconds, inspiratory time of 0.40 seconds for 15 minutes

DEVICE

SIPPV_VG_0_16

Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.16seconds, inspiratory time of 0.40 seconds for 15 minutes

DEVICE

SIPPV_VG_0_24

Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.24 seconds, inspiratory time of 0.40 seconds for 15 minutes

DEVICE

SIPPV_VG_0_32

Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.32 seconds, inspiratory time of 0.40 seconds for 15 minutes

DEVICE

SIPPV_VG_0_40

Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.40 seconds, inspiratory time of 0.40 seconds for 15 minutes

DEVICE

PSV_VG_0_08

Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.08 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes

DEVICE

PSV_VG_0_16

Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.16 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes

DEVICE

PSV_VG_0_24

Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.24 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes

DEVICE

PSV_VG_0_32

Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.32 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes

DEVICE

PSV_VG_0_40

Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.40 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Gusztav Belteki, M.D., Ph.D. · Cambridge University Hospitals NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

1 Day

Max Age

2 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• United Kingdom

Study Locations