Acute Respiratory FailureNCT04568642
Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2
A study of Acute Respiratory Failure and Acute Hypoxemic Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Respiratory Failure, Acute Hypoxemic Respiratory Failure, Acute Hypoxemic and Hypercapnic Respiratory Failure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital
Izmir, Turkey/izmir, 35200
About this study
Official title: Randomized Crossover Trial to Compare Closed-loop FiO2 Controller With Conventional Control of FiO2 During Mechanical Ventilation of Pediatric Patients
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
Read the detailed 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.
- Conditions
- Acute Respiratory Failure, Acute Hypoxemic Respiratory Failure, Acute Hypoxemic and Hypercapnic Respiratory Failure
- Being tested
- Activate FiO2 controller, Deactivate FiO2 controller
- Keywords
- Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS),, Acute lung injury (ALI),, SpO2, FiO2
- Medical subject headings
- Respiratory Insufficiency, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activate FiO2 controllerDevice
Closed-loop FiO2 controller will be activated in the experimental arm
Deactivate FiO2 controllerDevice
Closed-loop FiO2 controller will be deactivated in the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Device: conventional FiO2 will be selected by the clinician according to the SpO2 target Receives: Device: Deactivate FiO2 controller |
| Closed-loop | Experimental | Device: conventional FiO2 will be selected by the closed-loop algorithm according to the SpO2 target Receives: Device: Activate FiO2 controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimum range time
Percentage of time spent in the defined optimum SpO2 range (percentage)
Measured: 2 hour
Secondary outcomes (3)
Acceptable range time
Percentage of time spent in the defined acceptable SpO2 range (percentage)
Measured: 2 hour
Suboptimum range time
Percentage of time spent in the defined suboptimum SpO2 range (percentage)
Measured: 2 hour
Manuel adjustments
number of FiO2 controller manuel adjustments
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568642
- Sponsor's protocol ID
- 02020/404
- Status last verified
- Jan 2023
- First submitted
- 24 Sep 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20228688Pediatric 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.
PubMed 25647235Kneyber 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.
PubMed 28936698Mitra 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.
PubMed 29296004Waitz 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.
PubMed 25454938Dani 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.
PubMed 30632296Lal 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.
PubMed 26194933Platen 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.
PubMed 32223754Soydan 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.
PubMed 36091711
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Trial to Compare Closed-loop FiO2 Controller With Conventional Control of FiO2 During Mechanical Ventilation of Pediatric Patients
- ClinicalTrials.gov ID
- NCT04568642
- Acronym / sponsor ID
- 02020/404
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Device: Deactivate FiO2 controllerDevice: conventional FiO2 will be selected by the clinician according to the SpO2 target |
| Closed-loop | Experimental | Device: Activate FiO2 controllerDevice: conventional FiO2 will be selected by the closed-loop algorithm according to the SpO2 target |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activate FiO2 controllerClosed-loop FiO2 controller will be activated in the experimental arm | Device | Closed-loop |
| Deactivate FiO2 controllerClosed-loop FiO2 controller will be deactivated in the experimental arm | Device | Conventional |
Primary outcome
optimum range time
Time frame: 2 hour
Percentage of time spent in the defined optimum SpO2 range (percentage)
3 secondary outcomes
Acceptable range time
Time frame: 2 hour
Suboptimum range time
Time frame: 2 hour
Manuel adjustments
Time frame: 2 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 20228688Santschi 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.
- Background: PubMed 25647235Pediatric 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.
- Background: PubMed 28936698Kneyber 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.
- Background: PubMed 29296004Mitra 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.
- Background: PubMed 25454938Waitz 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.
- Background: PubMed 30632296Dani 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.
- Background: PubMed 26194933Lal 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.
- Background: PubMed 32223754Platen 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.
- Derived from this study: PubMed 36091711Soydan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Respiratory Failure and Acute Hypoxemic Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optimum range time (time frame: 2 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568642, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.