Skip to content

Pressure limit selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial

Pressure limit selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000886088
Acronym
AC/VG Pmax Study
Enrollment
26
Registered
2010-10-19
Start date
2008-10-29
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

The purpose of this project is to study how ventilators (breathing machines) support babies. We are investigating how we use the ventilator with the aim of better matching the babies' natural breathing patterns. The ventilator can vary the pressure it uses to adjust to your baby’s breathing. We set a maximum inflation pressure limit for how high it can go. Previous experience suggests that this having this limit set higher means babies can get a mixture of higher and lower pressures which may irritate some babies. Setting the limit lower means the ventilation pressures are more even. If the ventilator senses that the pressure limit is too low it will sound an alarm.

Interventions

Ventilator pressure limit settings will be compared in random order. The intervention periods (epochs) will last for 20 mins. Each epoch will be preceded by a 10 minute washout period. Infants will be ventilated using assist control volume guarantee mode with the Drager Babylog 8000plus ventilator throughout the study. The following selection methods will be compared: [A] The current standard setting in the neonatal intensive care unit (30 cm H2O) [B] A setting based upon the average delivered

Ventilator pressure limit settings will be compared in random order. The intervention periods (epochs) will last for 20 mins. Each epoch will be preceded by a 10 minute washout period. Infants will be ventilated using assist control volume guarantee mode with the Drager Babylog 8000plus ventilator throughout the study. The following selection methods will be compared: [A] The current standard setting in the neonatal intensive care unit (30 cm H2O) [B] A setting based upon the average delivered PIP for triggered inflations (identified by the researcher) + 5 cm H2O [C] A setting based upon the perceived 'working PIP' (as reported by the staff caring for the baby) + 5 cm H2O

Sponsors

Royal Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
24 Hours to No maximum
Healthy volunteers
No

Inclusion criteria

Stable ventilated infants, ventilated using assist control volume guarantee (AC/VG) for previous 24 hours.

Exclusion criteria

Ventilator changes in previous 4 hours, pH < 7.2, pCO2>80 mmHg, FiO2 > 0.8, acute pneumothoax/pulmonary interstitial emphysema, significant congenital abnormality, severe PVH, receiving muscle relaxants or morphine infusion > 20 ug/kg/hr

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026