search
Back to results

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

Primary Purpose

Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Close-loop FiO2 controller
Conventional
Sponsored by
Dr. Behcet Uz Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, Oxygen, SpO2

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aydin Obstetric and pediatrics HospitalRecruiting
  • Erzurum Regional Research and Training HospitalRecruiting
  • Cam Sakura Research and Training HospitalRecruiting
  • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Close-loop FiO2 Controller

Conventional

Arm Description

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

Conventional FiO2 adjustment by the clinician according to SpO2 values

Outcomes

Primary Outcome Measures

Percentage of time spent in optimal SpO2 range
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

Secondary Outcome Measures

Percentage of time spent in suboptimal SpO2 range
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Mean FiO2
Mean fraction of inspired oxygen
Mean SpO2/FiO2
Mean SpO2/FiO2
Number of manual adjustments
Frequency of manual adjustments of FiO2
Number of alarms
Frequency of alarms
Percentage of time with SpO2 signal available
Time with SpO2 signal available
Percentage of time with SpO2 below 88 and 85 percent
Duration of time with SpO2 <85 percent and <88 percent, respectively
Number of events with SpO2 below 88 and 85 percent
Frequency of SpO2 decreases <85 percent and <88 percent, respectively
Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent
Percentage of time that FiO2 is <40 percent, 60 percent and 100 percent, respectively
Total oxygen use
Volume of total oxygen used (in L)

Full Information

First Posted
January 27, 2023
Last Updated
September 14, 2023
Sponsor
Dr. Behcet Uz Children's Hospital
Collaborators
Hamilton Medical AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05714527
Brief Title
Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients
Acronym
CLOUDIMPP
Official Title
Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP)- a Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Behcet Uz Children's Hospital
Collaborators
Hamilton Medical AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, Oxygen, SpO2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Close-loop FiO2 Controller
Arm Type
Experimental
Arm Description
Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional FiO2 adjustment by the clinician according to SpO2 values
Intervention Type
Device
Intervention Name(s)
Close-loop FiO2 controller
Intervention Description
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
Intervention Name(s)
Conventional
Intervention Description
Conventional FiO2 adjustment by the clinician according to SpO2 values, by using the manual FiO2 knob.
Primary Outcome Measure Information:
Title
Percentage of time spent in optimal SpO2 range
Description
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Percentage of time spent in suboptimal SpO2 range
Description
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Time Frame
2 hours
Title
Mean FiO2
Description
Mean fraction of inspired oxygen
Time Frame
2 hours
Title
Mean SpO2/FiO2
Description
Mean SpO2/FiO2
Time Frame
2 hours
Title
Number of manual adjustments
Description
Frequency of manual adjustments of FiO2
Time Frame
2 hours
Title
Number of alarms
Description
Frequency of alarms
Time Frame
2 hours
Title
Percentage of time with SpO2 signal available
Description
Time with SpO2 signal available
Time Frame
2 hours
Title
Percentage of time with SpO2 below 88 and 85 percent
Description
Duration of time with SpO2 <85 percent and <88 percent, respectively
Time Frame
2 hours
Title
Number of events with SpO2 below 88 and 85 percent
Description
Frequency of SpO2 decreases <85 percent and <88 percent, respectively
Time Frame
2 hours
Title
Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent
Description
Percentage of time that FiO2 is <40 percent, 60 percent and 100 percent, respectively
Time Frame
2 hours
Title
Total oxygen use
Description
Volume of total oxygen used (in L)
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aydin Obstetric and pediatrics Hospital
City
Aydın
ZIP/Postal Code
09020
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ekin soydan
Phone
+905321003949
Email
dr-ekinsoydan@hotmail.com
Facility Name
Erzurum Regional Research and Training Hospital
City
Erzurum
ZIP/Postal Code
25180
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinar Hepduman, MD
Phone
+905531501115
Email
pnrhpdmn@gmail.com
Facility Name
Cam Sakura Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34001
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Colak, MD
Phone
+905554180903
Email
colakk@hotmail.com
Facility Name
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
City
Izmir
ZIP/Postal Code
35200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem Sandal, MD
Phone
+905067644688
Email
drozlemsarac@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ozlem Sandal
First Name & Middle Initial & Last Name & Degree
Gulhan Atakul

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28936698
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.
Results Reference
background
PubMed Identifier
26144575
Citation
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.
Results Reference
background
PubMed Identifier
29726010
Citation
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.
Results Reference
background
PubMed Identifier
31630690
Citation
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.
Results Reference
background
PubMed Identifier
36465920
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs