Optimising Ventilation in Preterms With Closed-loop Oxygen Control

October 21, 2024 updated by: King's College Hospital NHS Trust

Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants

Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored.

Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner.

With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a randomised controlled trial. The investigators aim to recruit a minimum of seventy premature ventilated infants born at less than 31 weeks gestation. Participants will be randomised to either closed-loop automated oxygen control or manually controlled oxygen from recruitment to successful extubation. The investigators will also record basic epidemiologic parameters and associated comorbidities that may impact on the duration of mechanical ventilation. Infants with known congenital anomalies will be excluded from the study.

Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to assent to the study.

Eligible infants whose parents consent to the study will be enrolled within 48 hours of initiation of mechanical ventilation.

Randomisation will be performed using an online randomisation generator. Patients will be ventilated using SLE6000 ventilators. Ventilation settings will be manually adjusted by the clinical team as per unit's protocol. The intervention group, in addition to standard care will be also connected to the OxyGenie closed-loop oxygen saturation monitoring software (SLE). This software uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.

The nurse-to-patient ratio will be according to the unit's protocol that is determined on the patient's acuity.

Patients will be studied from enrolment until successful extubation. If an infant fails extubation and requires reintubation within 48 hours, he will be studied in his initial arm if less than 28 days old. Therefore, for those infants randomised at the intervention group CLAC will resume. Preterm infants that remain ventilated beyond day 28 of life will continue at their study arm (closed-loop automated oxygen control or manual oxygen control) till their first extubation attempt.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth

Exclusion Criteria:

  • Preterm infants above 31 weeks completed gestation or term born infants
  • Infants with major congenital abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Manual oxygen control
Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol.
Other: Closed-loop automated oxygen control
Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary
Device: Closed-loop automated oxygen control (Oxygenie, SLE 6000)
The OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of mechanical ventilation
Time Frame: Through study completion, an average of 2 years
The duration of mechanical ventilation will be measured in median (interquartile range) number of days of ventilation for participants in each group.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of time spent within target oxygen saturation range.
Time Frame: Through study completion, an average of 2 years
Target oxygen saturation range for our preterm population is 90-95% as per local guideline. The time spent in target range will be calculated as a percentage of the total time of monitoring.
Through study completion, an average of 2 years
Number of manual adjustments to the inspired oxygen concentration required by clinical staff.
Time Frame: Through study completion, an average of 2 years
The number of manual adjustment will be calculated by reviewing the infant's medical records.
Through study completion, an average of 2 years
Number of days on oxygen.
Time Frame: Through study completion, an average of 2 years
The number of days each participant will require supplementary oxygen to maintain oxygen saturation levels within target range.
Through study completion, an average of 2 years
Length of Intensive Care stay
Time Frame: Through study completion, an average of 2 years
The days each participant is admitted at the Neonatal Intensive Care
Through study completion, an average of 2 years
A diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age
Time Frame: Through study completion, an average of 2 years
The diagnosis of BPD will be calculated by reviewing the infant's medical records and respiratory status.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Collaborators

King's College London

Investigators

  • Principal Investigator: Anne Greenough, Professor, King's College Hospital/ King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297749
  • KCH21-111 (Other Identifier: King's College Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infant, Premature, Diseases

Clinical Trials on Closed-loop automated oxygen control (Oxygenie, SLE 6000)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe