NCT05714527: CLOUDIMPP

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

Completed NA Last updated 29 October 2024

What this trial tests

NA trial testing Close-loop FiO2 controller in Respiratory Failure in 30 participants. Completed in 31 August 2024.

Timeline

30 January 2023

Primary endpoint
31 December 2023

31 August 2024

Quick facts

Lead sponsor	Dr. Behcet Uz Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	30 January 2023
Primary completion	31 December 2023
Estimated completion	31 August 2024
Sites	4 locations across Turkey (Türkiye)

Drugs / interventions tested

• Close-loop FiO2 controller
• Conventional

Conditions studied

• Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

Dr. Behcet Uz Children's Hospital

Who can join

Adults 1 Month to 18, any sex, with Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Closed-loop oxygen usage during invasive mechanical ventilation of pediatric patients (CLOUDIMPP): a randomized controlled cross-over study.
   Atakul G, Ceylan G, Sandal O, Soydan E, et al · · 2024 · cited 1× · PMID 39318593 · DOI 10.3389/fmed.2024.1426969
2. Protocol for Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP): A Randomized Cross-Over Study
   Atakul G, Ceylan G, Sandal O, Soydan E, et al · · 2024 · DOI 10.21203/rs.3.pex-2245/v1
3. Closed-Loop O2 Use During Invasive Mechanical Ventilation of Pediatric Patients (CLOUDIMPP): A Randomized Cross-Over Study
   Atakul G, Ceylan G, Sandal O, Soydan E, et al · · 2023 · DOI 10.21203/rs.3.rs-2908224/v1