Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2

Acute Respiratory Failure Clinical Trial

Official title:

Randomized Crossover Trial to Compare Closed-loop FiO2 Controller With Conventional Control of FiO2 During Mechanical Ventilation of Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568642
• Other study ID #: 02020/404
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2023
• Source: Dr. Behcet Uz Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The study has a crossover design. Patients will start in standard ASV 1.1 settings, then attending physician will assess the ventilation parameters according to study protocol and will note them in the case report form as he starts the data recording with MemoryBox (MB)in the mixed mode. Afterwards, the clinician will start the first phase by either keeping the patient in ASV 1.1 without any closed-loop controllers activated or switching to ASV 1.1 with only FiO2 controller activated according to the randomization. After 2.5 hours of recording in the first phase, the clinician will switch the patient to the second phase regarding randomization order. If the patient was ventilated without FiO2 controller activated in the first phase, the controller will be activated in the second phase. The patient will stay in the second phase for 2.5 hours as well. The first 0.5 hours of the first phase will be considered as run-in phase and the first 0.5 hours of the second phase will be considered as wash-out phase. Therefore the first 0.5 hours of each phase will be excluded from data analysis due to cross-over study design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Hypoxemic and Hypercapnic Respiratory Failure
• Acute Hypoxemic Respiratory Failure
• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Activate FiO2 controller
Closed-loop FiO2 controller will be activated in the experimental arm
• Deactivate FiO2 controller
Closed-loop FiO2 controller will be deactivated in the experimental arm

Locations

Country	Name	City	State
Turkey	The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital	Izmir	Turkey/izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optimum range time	Percentage of time spent in the defined optimum SpO2 range (percentage)	2 hour
Secondary	Acceptable range time	Percentage of time spent in the defined acceptable SpO2 range (percentage)	2 hour
Secondary	Suboptimum range time	Percentage of time spent in the defined suboptimum SpO2 range (percentage)	2 hour
Secondary	Manuel adjustments	number of FiO2 controller manuel adjustments	2 hour