Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery (FreeO2PostOp)

Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Major Thoracic and Abdominal Surgery
• Intervention / Treatment: Device: FreeO2 v2.2 active; Device: FreeO2 v2.2 with manual oxygenation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québéc, Canada, G1V4G5
    • Hôpital Laval - Québéc
• France
  • Brest, France
    • Brest, University Hospital
  • Clermont-Ferrand, France, 63000
    • CHU Clermont-Ferrand
  • Montpellier, France, 34295
    • CHU Montpellier
  • Poitiers, France, 86021
    • CHU Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FreeO2 v2.2 active; Automatic Oxygen Administration	Device: FreeO2 v2.2 active; Automatic adjustment of oxygen through the "Free O2" device.; "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
Active Comparator: FreeO2 v2.2 with manual oxygenation; Manual Oxygen Administration	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...).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the target zone of oxygen saturation	The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nursing workload	nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures	3 days
Time spent in a area of severe desaturation (SpO2 <85%)	Time spent in a area of severe desaturation (SpO2 <85%) evaluated by freeO2 device	3 days
Time spent in a hyperoxia area (SpO2> 98%).	Time spent in a hyperoxia area (SpO2> 98%) evaluated by freeO2 device	3 days
Maintaining EtCO2 in a selected area	Maintaining EtCO2 in a selected area evaluated by freeO2 device	3 days
Oxygen consumption measured at the end of administration	Oxygen consumption measured at the end of administration	3 days
Duration of oxygen administration during hospitalization	Duration of oxygen administration during hospitalization	3 days
Number of complications related to the administration of oxygen	Number of complications related to the administration of oxygen	28 days max
Frequency of use of ventilation (invasive or noninvasive )	Frequency of use of ventilation (invasive or noninvasive )	28 days max
Duration of hospitalization	Duration of hospitalization	28 days max

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Erwan L'HER, University Hospital, Brest

Publications and helpful links

General Publications

• L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, Lellouche F. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021 Jan 5;57(1):2000182. doi: 10.1183/13993003.00182-2020. Print 2021 Jan.
• L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: RB14-060; CHRU de Brest (Registry Identifier: RB14-060)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO