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Comparison of Automated Oxygen Control With and Without Automated Pressure Control in Preterm Ventilated Infants.

NCT03865069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-07-20

No results posted yet for this study

Summary

This is a cross-over randomized study. Eligible participants are preterm infants born at less than 37 weeks gestation (23+0 to 36+6 weeks), who are receiving conventional mechanical ventilation through an endotracheal tube and have a need for supplemental oxygen at the time of enrolment. The planned sample size is 19 subjects completing the study with both arms (38 study periods). The objective of this crossover study is to evaluate the efficacy of the automatic oxygen control function with or without Volume Guarantee®(automatic control of ventilator pressure to deliver the set volume) mode of ventilation in keeping oxygen levels in the safe target range (90 to 95%) in ventilated preterm infants requiring oxygen therapy.

Conditions

  • Oxygen Saturation Targetting in Preterm Ventilated Infants

Interventions

OTHER

Mode of ventilation (Volume Guarantee)®

This is a volume-targeted mode of ventilation aimed at delivering the set tidal volume of gas by automatically adjusting the peak inspiratory pressure (PIP) on a breath-by-breath basis. Theoretically this should minimise variation in tidal volume delivery as lung compliance and the infant's condition changes. This function is achieved by an automated servo-controlled mechanism. The upper PIP limit can be set by the clinician as a safety mechanism.

OTHER

Mode of ventilation (Volume control Ventilation)

Volume-Controlled ventilation (VCV) is a type of 'volume targeted' mode. It aims to target be supported the desired tidal volume by delivering a set volume (chosen by the clinician) irrespective of the underlying lung mechanics. The ventilator will generate whatever peak inspiratory pressure is necessary to deliver this volume. There is constant inspiratory flow pattern (a square flow waveform) and peak volume and inspiratory pressure delivery are achieved at the end of inspiration. During the 'control period' of 12 hours without VG, infants will using VCV A/C (assist control) as is our current clinical standard.

Sponsors & Collaborators

  • South Tees Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Vrinda Nair, MBBS,FRCPCH · South Tees NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
23 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-07-12
Completion
2020-07-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865069 on ClinicalTrials.gov