Clinical trial NCT02546830: Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery
Official title: Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Thoracic and Abdominal Surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time spent in the target zone of oxygen saturation
timeFrame: 3 days
Secondary outcomes:
measure: nursing workload
timeFrame: 3 days
measure: Time spent in a area of severe desaturation (SpO2 <85%)
timeFrame: 3 days
measure: Time spent in a hyperoxia area (SpO2> 98%).
timeFrame: 3 days
measure: Maintaining EtCO2 in a selected area
timeFrame: 3 days
measure: Oxygen consumption measured at the end of administration
timeFrame: 3 days
measure: Duration of oxygen administration during hospitalization
timeFrame: 3 days
measure: Number of complications related to the administration of oxygen
timeFrame: 28 days max
measure: Frequency of use of ventilation (invasive or noninvasive )
timeFrame: 28 days max
measure: Duration of hospitalization
timeFrame: 28 days max
Other outcomes:
Locations:
city: Québéc
country: Canada
facility: Hôpital Laval - Québéc
city: Brest
country: France
facility: Brest, University Hospital
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Montpellier
country: France
facility: CHU Montpellier
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: University Hospital, Brest
name: Erwan L'HER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.