NCT03306524

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

September 25, 2017

Last Update Submit

May 16, 2019

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

mechanical ventilationSIPPVPSVDevice flowCircuit flowSlope timeneonatal intensive care

Outcome Measures

Primary Outcomes (1)

  • End tidal CO2 measurement

    Primary outcome will be the difference in end-tidal CO2 concentration during the epochs with slope times of 0.40 and 0.08 sec.

    One year

Study Arms (10)

SIPPV_VG_0_08

EXPERIMENTAL

SIPPV VG ventilation for 15 minutes slope time = 0.08 seconds inspiratory time = 0.40 seconds

Device: SIPPV_VG_0_08

PSV_VG_0_08

EXPERIMENTAL

PSV VG ventilation for 15 minutes slope time = 0.08 seconds maximum inspiratory time = 0.60 seconds

Device: PSV_VG_0_08

SIPPV_VG_0_16

EXPERIMENTAL

SIPPV VG ventilation for 15 minutes slope time = 0.16 seconds inspiratory time = 0.40 seconds

Device: SIPPV_VG_0_16

PSV_VG_0_16

EXPERIMENTAL

PSV VG ventilation for 15 minutes slope time = 0.16 seconds maximum inspiratory time = 0.60 seconds

Device: PSV_VG_0_16

SIPPV_VG_0_24

EXPERIMENTAL

SIPPV VG ventilation for 15 minutes slope time = 0.24 seconds inspiratory time = 0.40 seconds

Device: SIPPV_VG_0_24

PSV_VG_0_24

EXPERIMENTAL

PSV VG ventilation for 15 minutes slope time = 0.24 seconds maximum inspiratory time = 0.60 seconds

Device: PSV_VG_0_24

SIPPV_VG_0_32

EXPERIMENTAL

SIPPV VG ventilation for 15 minutes slope time = 0.32 seconds inspiratory time = 0.40 seconds

Device: SIPPV_VG_0_32

PSV_VG_0_32

EXPERIMENTAL

PSV VG ventilation for 15 minutes slope time = 0.32 seconds maximum inspiratory time = 0.60 seconds

Device: PSV_VG_0_32

SIPPV_VG_0_40

EXPERIMENTAL

SIPPV VG ventilation for 15 minutes slope time = 0.32 seconds inspiratory time = 0.40 seconds

Device: SIPPV_VG_0_40

PSV_VG_0_40

EXPERIMENTAL

PSV VG ventilation for 15 minutes slope time = 0.40 seconds maximum inspiratory time = 0.60 seconds

Device: PSV_VG_0_40

Interventions

SIPPV_VG_0_08DEVICE

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

SIPPV_VG_0_08
SIPPV_VG_0_16DEVICE

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

SIPPV_VG_0_16
SIPPV_VG_0_24DEVICE

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

SIPPV_VG_0_24
SIPPV_VG_0_32DEVICE

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

SIPPV_VG_0_32
SIPPV_VG_0_40DEVICE

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

SIPPV_VG_0_40
PSV_VG_0_08DEVICE

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

PSV_VG_0_08
PSV_VG_0_16DEVICE

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

PSV_VG_0_16
PSV_VG_0_24DEVICE

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

PSV_VG_0_24
PSV_VG_0_32DEVICE

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

PSV_VG_0_32
PSV_VG_0_40DEVICE

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

PSV_VG_0_40

Eligibility Criteria

Age1 Day - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight \< 2 kg;
  • Ventilated with SIPPV-VG modes,
  • Informed parental consent,
  • Clinician assent.

You may not qualify if:

  • Baby's respiratory condition unstable (Inspired oxygen (FiO2) \> 50%, PaCO2 \> 8.5kPa or \<5kPa in the last 12 hours)
  • Extubation planned in the next 12 hours;
  • Neonatal or surgical procedure in the last 12 hours or planned in the next 12 hours;
  • Significant pneumothorax requiring drainage;
  • Gas leak around the endotracheal tube \>50%; #
  • No arterial access;
  • The responsible clinician does not agree with recruitment;
  • Parents do not consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust

Cambridge, CB20QQ, United Kingdom

Location

Related Publications (4)

  • Attar MA, Donn SM. Mechanisms of ventilator-induced lung injury in premature infants. Semin Neonatol. 2002 Oct;7(5):353-60. doi: 10.1053/siny.2002.0129.

    PMID: 12464497BACKGROUND

  • Nafday SM, Green RS, Lin J, Brion LP, Ochshorn I, Holzman IR. Is there an advantage of using pressure support ventilation with volume guarantee in the initial management of premature infants with respiratory distress syndrome? A pilot study. J Perinatol. 2005 Mar;25(3):193-7. doi: 10.1038/sj.jp.7211233.

    PMID: 15674409BACKGROUND

  • Bach KP, Kuschel CA, Oliver MH, Bloomfield FH. Ventilator gas flow rates affect inspiratory time and ventilator efficiency index in term lambs. Neonatology. 2009;96(4):259-64. doi: 10.1159/000220765. Epub 2009 May 27.

    PMID: 19478530BACKGROUND

  • Bach KP, Kuschel CA, Hooper SB, Bertram J, McKnight S, Peachey SE, Zahra VA, Flecknoe SJ, Oliver MH, Wallace MJ, Bloomfield FH. High bias gas flows increase lung injury in the ventilated preterm lamb. PLoS One. 2012;7(10):e47044. doi: 10.1371/journal.pone.0047044. Epub 2012 Oct 8.

    PMID: 23056572BACKGROUND

Study Officials

  • Gusztav Belteki, M.D., Ph.D.

    Cambridge University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Neonates
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Ten different interventions (with changing slope time or ventilation mode) will be compared in a crossover design. Each intervention will be given for 15 minutes. For details of the intervention see study design details.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neonatologist

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 11, 2017

Study Start

July 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

GB(1)