Is bias gas flow in ventilated preterm babies related to lung injury and risk of bronchopulmonary dysplasia?

Ventilator bias gas flows in extremely preterm or extremely low birth weight babies: does a low bias gas flow compared with standard settings decrease concentrations of IL-8 in tracheal secretions and blood and the number of ventilated days?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000628943

Acronym

FLoRa: Flows at Lower Rates

Enrollment

180

Registered

2011-06-21

Start date

2012-07-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mechanical ventilation of preterm babies has increased their survival over the last decades; however, ventilation also results in injury to the delicate immature lung. Several aspects of ventilation have been identified as contributing to this injury, including the pressure generated by the ventilator and the volume of gas delivered, which have led to advances in ventilatory strategies. To generate the pressure and tidal volume necessary to ventilate a patient, a ventilator applies a continuous bias gas flow running through the ventilator circuit. During ventilation of the preterm baby, this bias gas flow is normally set at 8-10 L/min, independent of babies’ weights and without evidence for this to be the correct setting. However, high compared to low ventilator bias gas flows have been proven to be more injurious for the immature lamb lung. This study will compare preterm babies ventilated at either the standard gas flow of 10 L/min, or a low gas flow of 4 L/min. Outcomes will be measurement of levels of inflammatory markers and duration and intensity of respiratory support

Interventions

Arm 1:Conventional ventilation via ETT at a bias gas flow of 4 L/min Arm 2: Conventional ventilation via ETT at a bias gas flow of 10 L/min Duration; each time ventilation is indicated up to 36 weeks’ corrected gestational age

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 7 Days

Healthy volunteers

Inclusion criteria

Preterm baby born before 28 weeks of gestation or birth weight < 1,000 g and the need for mechanical ventilation in the first week of life

Exclusion criteria

Congenital cardio-respiratory anomalies and known chromosomal or genetic abnormalities

Outcome results