Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2

NCT04568642 | Completed

• 1 other identifier: 02020/404
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. \[1\] For healthy lung, PEMVECC proposed the SpO2\>95% when breathing a FiO2 of 21%.\[2\] 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. \[3\] This study aims to compare the closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation of pediatric patients

Conditions

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

Keywords

Acute respiratory failure (ARF); Pediatric acute respiratory distress syndrome (PARDS),; Acute lung injury (ALI),; SpO2; FiO2

Outcome Measures

Primary Outcomes (1)

• optimum range time

  Percentage of time spent in the defined optimum SpO2 range (percentage)

  2 hour

Secondary Outcomes (3)

• Acceptable range time

  2 hour

• Suboptimum range time

  2 hour

• Manuel adjustments

  2 hour

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Device: conventional FiO2 will be selected by the clinician according to the SpO2 target

Device: Deactivate FiO2 controller

Closed-loop

EXPERIMENTAL

Device: conventional FiO2 will be selected by the closed-loop algorithm according to the SpO2 target

Device: Activate FiO2 controller

Interventions

Activate FiO2 controller DEVICE

Closed-loop FiO2 controller will be activated in the experimental arm

Closed-loop

Deactivate FiO2 controller DEVICE

Closed-loop FiO2 controller will be deactivated in the experimental arm

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 between 1 months and 18 years
• Patients above 7kg of IBW
• Informed consent was signed by next of kin
• Requiring FiO2 ≥ 25% to keep SpO2 in the target ranges defined by the clinician

You may not qualify if:

• Candidate for extubation in the next 5 hours.
• Patient included in another interventional study in the last 30 days
• Hemodynamically instable patients (defined as a need for continuous infusion of epinephrine or norepinephrine \> 1 mg/h)
• Patients with congenital or acquired hemoglobinopathies effecting SpO2 measurement
• 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

Study Sites (1)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital

Izmir, Turkey/izmir, 35200, Turkey (Türkiye)

Location

Related Publications (9)

• Santschi M, Jouvet P, Leclerc F, Gauvin F, Newth CJ, Carroll CL, Flori H, Tasker RC, Rimensberger PC, Randolph AG; PALIVE Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); European Society of Pediatric and Neonatal Intensive Care (ESPNIC). Acute lung injury in children: therapeutic practice and feasibility of international clinical trials. Pediatr Crit Care Med. 2010 Nov;11(6):681-9. doi: 10.1097/PCC.0b013e3181d904c0.

  PMID: 20228688 BACKGROUND

• Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.

  PMID: 25647235 BACKGROUND

• 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

• Mitra S, Singh B, El-Naggar W, McMillan DD. Automated versus manual control of inspired oxygen to target oxygen saturation in preterm infants: a systematic review and meta-analysis. J Perinatol. 2018 Apr;38(4):351-360. doi: 10.1038/s41372-017-0037-z. Epub 2018 Jan 2.

  PMID: 29296004 BACKGROUND

• Waitz M, Schmid MB, Fuchs H, Mendler MR, Dreyhaupt J, Hummler HD. Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. J Pediatr. 2015 Feb;166(2):240-4.e1. doi: 10.1016/j.jpeds.2014.10.007. Epub 2014 Nov 18.

  PMID: 25454938 BACKGROUND

• Dani C. Automated control of inspired oxygen (FiO2 ) in preterm infants: Literature review. Pediatr Pulmonol. 2019 Mar;54(3):358-363. doi: 10.1002/ppul.24238. Epub 2019 Jan 10.

  PMID: 30632296 BACKGROUND

• Lal M, Tin W, Sinha S. Automated control of inspired oxygen in ventilated preterm infants: crossover physiological study. Acta Paediatr. 2015 Nov;104(11):1084-9. doi: 10.1111/apa.13137.

  PMID: 26194933 BACKGROUND

• Platen PV, Pomprapa A, Lachmann B, Leonhardt S. The dawn of physiological closed-loop ventilation-a review. Crit Care. 2020 Mar 29;24(1):121. doi: 10.1186/s13054-020-2810-1.

  PMID: 32223754 BACKGROUND

• Soydan E, Ceylan G, Topal S, Hepduman P, Atakul G, Colak M, Sandal O, Sari F, Karaarslan U, Novotni D, Schultz MJ, Agin H. Automated closed-loop FiO2 titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients-A randomized crossover clinical trial. Front Med (Lausanne). 2022 Aug 25;9:969218. doi: 10.3389/fmed.2022.969218. eCollection 2022.

  PMID: 36091711 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Acute Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Injury; Lung 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 doctor, Head of pediatric intensive care unit (PICU)

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 29, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

TU (1)