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

NCT05714527 | Completed

• 1 other identifier: 2022/750
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Respiratory Failure

Keywords

Acute respiratory failure (ARF); Pediatric acute respiratory distress syndrome (PARDS); Closed-loop; Oxygen; SpO2

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in optimal SpO2 range

  The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

  2 hours

Secondary Outcomes (10)

• Percentage of time spent in suboptimal SpO2 range

  2 hours

• Mean FiO2

  2 hours

• Mean SpO2/FiO2

  2 hours

• Number of manual adjustments

  2 hours

• Number of alarms

  2 hours

Study Arms (2)

Close-loop FiO2 Controller

EXPERIMENTAL

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

Device: Close-loop FiO2 controller

Conventional

ACTIVE COMPARATOR

Conventional FiO2 adjustment by the clinician according to SpO2 values

Device: Conventional

Interventions

Close-loop FiO2 controller 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.

Close-loop FiO2 Controller

Conventional DEVICE

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

Conventional

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (4)

Aydin Obstetric and pediatrics Hospital

Aydin, 09020, Turkey (Türkiye)

Location

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

Location

Cam Sakura Research and Training Hospital

Istanbul, 34001, Turkey (Türkiye)

Location

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, 35200, Turkey (Türkiye)

Location

Related Publications (6)

• Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22.

  PMID: 28936698 BACKGROUND

• van Kaam AH, Hummler HD, Wilinska M, Swietlinski J, Lal MK, te Pas AB, Lista G, Gupta S, Fajardo CA, Onland W, Waitz M, Warakomska M, Cavigioli F, Bancalari E, Claure N, Bachman TE. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. J Pediatr. 2015 Sep;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012. Epub 2015 Jul 2.

  PMID: 26144575 BACKGROUND

• Lui K, Jones LJ, Foster JP, Davis PG, Ching SK, Oei JL, Osborn DA. Lower versus higher oxygen concentrations titrated to target oxygen saturations during resuscitation of preterm infants at birth. Cochrane Database Syst Rev. 2018 May 4;5(5):CD010239. doi: 10.1002/14651858.CD010239.pub2.

  PMID: 29726010 BACKGROUND

• Maiwald CA, Niemarkt HJ, Poets CF, Urschitz MS, Konig J, Hummler H, Bassler D, Engel C, Franz AR; FiO2-C Study Group. Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy. BMC Pediatr. 2019 Oct 21;19(1):363. doi: 10.1186/s12887-019-1735-9.

  PMID: 31630690 BACKGROUND

• Sandal O, Ceylan G, Topal S, Hepduman P, Colak M, Novotni D, Soydan E, Karaarslan U, Atakul G, Schultz MJ, Agin H. Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study. Front Med (Lausanne). 2022 Nov 16;9:1046902. doi: 10.3389/fmed.2022.1046902. eCollection 2022.

  PMID: 36465920 BACKGROUND

• Atakul G, Ceylan G, Sandal O, Soydan E, Hepduman P, Colak M, Zimmermann JM, Novotni D, Karaarslan U, Topal S, Agin H. Closed-loop oxygen usage during invasive mechanical ventilation of pediatric patients (CLOUDIMPP): a randomized controlled cross-over study. Front Med (Lausanne). 2024 Sep 10;11:1426969. doi: 10.3389/fmed.2024.1426969. eCollection 2024.

  PMID: 39318593 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: January 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: August 31, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)