Closed Loop Oxygen Control in INtubated Critically Ill Patients

NCT06829732 | Recruiting

• 1 other identifier: PT_UCI_RESP1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The deleterious effects of alveolar hyperoxia and (severe) hyperoxaemia are well described. Achieving safe and efficient oxygenation may be challenging. The hypothesis of the present study is that closed-loop oxygen control in intubated and mechanically ventilated critically ill patients improves oxygen administration compared with standard manual oxygen titrations. A single-blind, randomised crossover clinical trial assessing the efficacy and safety of the use of a closed-loop oxygen control versus manual oxygen titration in patients receiving mechanical ventilation has been designed. Patients will be randomised to receive first either closed-loop oxygen control (CLOC) or manual oxygen titration (MOT). The percentage of time spent in optimal and sub-optimal SpO2 (oxygen saturation by pulse oximetry) ranges will be calculated for each period.

Conditions

Hypoxemic Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Efficacy outcome:

  To compare the percentage of time spent in a predefined optimal SpO2 (oxygen saturation by pulse oximetry) range between closed-loop oxygen control and manual oxygen titration

  Hour 1 to 4

Secondary Outcomes (13)

• Percentage of time with SpO2 (oxygen saturation by pulse oximetry) in sub-optimal ranges

  Hour 1 to 4

• Percentage of time with SpO2 (oxygen saturation by pulse oximetry) out of range

  Hour 1 to 4

• Number of manual adjustments

  Hour 1 to 4

• Mean SpO2/FiO2 (oxygen saturation by pulse oximetry to fraction of inspired oxygen ratio) between the two methods

  Hour 1 to 4

• Mean FiO2 (fraction of inspired oxygen) between the two methods of oxygen titration

  Hour 1 to 4

Study Arms (2)

1. closed-loop oxygen control (CLOC)

EXPERIMENTAL

Automatic Oxygen management sets the Oxygen control according to the patient's measured SpO2 and the operator-set SpO2 target range during 4h.

Device: closed-loop oxygen control (CLOC)

2. manual oxygen titration (MOT)

ACTIVE COMPARATOR

Conventional oxygen manual management according to SpO2 target range set by clinician, during 4h.

Device: 2. manual oxygen titration (MOT)

Interventions

closed-loop oxygen control (CLOC) DEVICE

HAMILTON-C6 (Hamilton Medical, Bonaduz, Switzerland) ventilators will be used. It allows for O2 Assist software, that will be installed on all C6 ventilators before the start of this study. Automatic Oxygen management sets the Oxygen control according to the patient's measured SpO2 and the operator-set SpO2 target range. The Oxygenation controller will be activated for 4h and adjusts the Oxygen according to patient's measured SpO2.

1. closed-loop oxygen control (CLOC)

2. manual oxygen titration (MOT) DEVICE

O2 will be manually set according to SpO2 target during a 4h period.

2. manual oxygen titration (MOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ICU who are expected to require invasive mechanical ventilation for at least 8 hours and are expected to stay respiratory stable´ in the upcoming 8 hours.
• Age older than 18 years old.
• 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.

You may not qualify if:

• Low quality on the SpO2 measurement using finger and ear sensor (quality index \<60%).
• Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h.
• Severe acidosis (pH ≤ 7.30).
• Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease.
• Patient under guardianship or deprived of liberties.
• Impossibility to give informed consent by both patient and family (i.e. language barrier).
• Patient included in another interventional research study under consent with similar outcome.

Sponsors & Collaborators

• Parc Taulí Hospital Universitari: lead

Study Sites (1)

Parc Tauli Hospital Universitary

Sabadell, Barcelona, 08028, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Critical Care Department

Model Details: Every patient included will be randomize to recieved both arm in different order. Every period will last for 4 h.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 17, 2025
• Study Start: April 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

ES (1)