Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.

The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Automatic Administration of Oxygen During Respiratory Distress

NCT02027181

Acute Respiratory Distress Syndrome Hypoxemia

COMPLETED PHASE1

The Effect of Continuous Pulse Oximetry Monitoring and Early Intervention Using Wearable Device on the Incidence of Postoperative Hypoxemia

NCT04694599

Postoperative Respiratory Complication

UNKNOWN NA

Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation

NCT02832817

Arterial Pulsed Oxygen Saturation

UNKNOWN

Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit.

NCT05409573

Critically Ill

RECRUITING NA

Pulse Oximetry With Automated Verbal Prompts

NCT02930863

Hypoxemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Thoracic and Abdominal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FreeO2 v2.2 active

Automatic Oxygen Administration

Group Type EXPERIMENTAL

FreeO2 v2.2 active

Intervention Type DEVICE

* Automatic adjustment of oxygen through the "Free O2" device.
* "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

FreeO2 v2.2 with manual oxygenation

Manual Oxygen Administration

Group Type ACTIVE_COMPARATOR

FreeO2 v2.2 with manual oxygenation

Intervention Type DEVICE

* Manual adjustment of oxygen without the assistance of the "FreeO2" device.
* Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FreeO2 v2.2 active

* Automatic adjustment of oxygen through the "Free O2" device.
* "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

Intervention Type DEVICE

FreeO2 v2.2 with manual oxygenation

* Manual adjustment of oxygen without the assistance of the "FreeO2" device.
* Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Preoperative anesthetic visit for major thoracic or abdominal surgery ( ARISCAT risk score ≥ 26) with general anesthesia
* Patient consent

Randomization Criteria:

* Admission in post-anesthesia care unit after major thoracic or abdominal surgery
* Randomization and device establishment within a time less than one hour after the endotracheal intubation
* Availability of the prototype FreeO2
* Absence of criteria of gravity justifying immediately a different technique of ventilatory support:

* Disturbance of consciousness with a Glasgow Coma Score ≤ 12
* Serious ventricular rhythm disorders
* Hemodynamic instability (SBP \<80mmHg or recourse to vasopressors)
* Cardiac or respiratory arrest
* pH \< 7.35 and PaCO2 \> 55 mm Hg
* Necessity of an oxygen flow less than 15 L / min to maintain a SpO2 higher than 92%.
* Absence of necessity of a urgent surgery
* Oxygen saturation measured by Spo2 sensor

Exclusion Criteria

* BMI ≥ 35 kg/m2
* Obstructive sleep Apnea (with or without Mechanical therapy)
* Emergency Surgery for life-threatening
* Age \<18 years
* Pregnant women, lactating
* perturbed or non-cooperative patient

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No