Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During mechanical ventilation (MV) hypoxemic or hyperoxemic events should be carefully monitored and a quick response should be provided by the caregiver at the bedside. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest to measure SpO2 in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease. There were no predefined upper and lower limits for oxygenation in pediatric guidelines, however, Pediatric acute lung injury consensus conference PALICC guidelines proposed SpO2 between 92 - 97% when positive end-expiratory pressure (PEEP) is smaller than 10 cm H2O and SpO2 of 88 - 92% when PEEP is bigger or equal to 10 cm H2O. For healthy lung, PEMVECC proposed the SpO2\>95% when breathing a FiO2 of 21%. As a rule of thumb, the minimum fraction of inspired O2 (FiO2) to reach these targets should be used. A recent Meta-analyze showed that automated FiO2 adjustment provides a significant improvement of time in target saturations, reduces periods of hyperoxia, and severe hypoxia in preterm infants on positive pressure respiratory support. This study aims to compare the closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation of pediatric patients

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2

NCT04568642

Acute Respiratory Failure Acute Hypoxemic Respiratory Failure Acute Hypoxemic and Hypercapnic Respiratory Failure

COMPLETED NA

Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)

NCT06374589

Acute Hypoxemic Respiratory Failure Acute Hypercapnic Respiratory Failure Respiratory Depression +1 more

RECRUITING NA

PRactice of VENTilation in Critically Ill PEDiatric Patients

NCT06220825

Critical Illness Respiratory Failure

RECRUITING

Oxygen Consumption In Critically Ill Children

NCT01521195

Extracorporeal Membrane Oxygenation

COMPLETED NA

Closed-loop Synchronization Versus Conventional Synchronization

NCT05731024

Acute Respiratory Failure Pediatric Respiratory Distress Syndrome

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Close-loop FiO2 Controller

Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.

Group Type EXPERIMENTAL

Close-loop FiO2 controller

Intervention Type DEVICE

Close-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range.

Conventional

Conventional FiO2 adjustment by the clinician according to SpO2 values

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type DEVICE

Conventional FiO2 adjustment by the clinician according to SpO2 values, by using the manual FiO2 knob.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Close-loop FiO2 controller

Close-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range.

Intervention Type DEVICE

Conventional

Conventional FiO2 adjustment by the clinician according to SpO2 values, by using the manual FiO2 knob.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pediatric patients older than 1 month and younger than18 years of age; hospitalized at the PICU with the intention of treatment with IMV at least for the upcoming 5 hours
* Requiring FiO2 ≥ 25% to keep SpO2 in the target ranges defined by the clinician
* Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation

Exclusion Criteria

* Patient with indication for immediate noninvasive ventilation (NIMV), High flow oxygen therapy (HFOT)
* Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h
* Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the SpO2 sensor, which is displayed by a red or orange colour bar)
* Severe acidosis (pH ≤ 7.25)
* Pregnant woman
* Patients deemed at high risk for the need of non-invasive mechanical ventilation within the next 5 hours
* Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital
* Diseases or conditions which may affect transcutaneous SpO2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (CO) poisoning, sickle cell disease
* Formalized ethical decision to withhold or withdraw life support
* Patient included in another interventional research study under consent
* Patient already enrolled in the present study in a previous episode of acute respiratory failure

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No