ICU PatientFALCONNCT04446559
Sitting Position and Blood Oxygenation in ICU Patient
A study testing Sitting in chair position in people with ICU Patient, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The positioning of the ICU patient is a daily concern of the medical and paramedical teams. Developments in emergency medicine and sedation and analgesia techniques have made it possible to reduce patient mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patient
- What is being tested?
- Sitting in chair position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2020to 6 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old in intensive care unit (ICU) or surgical intensive care unit (SICU)
- Intubated and under mechanical invasive ventilation for at least 24 hours or under non-invasive ventilation for more than 12 hours a day or under continuous high-flow nasal oxygen therapy for more than 24 hours or alternating NIV/HFNO.
- Patient or next of kin who has expressed consent to participate in the study
Who cannot join
- Tracheotomized patient
- Patient with a contraindication to sitting in a chair
- Deep vein thrombosis not effectively anticoagulated
- Fracture or orthopaedic disorder contra indicating mobilization
- Lung Embolism
- Hemodynamic instability with Average Arterial Pressure < 65 mmHg or a vasopressor amine dose greater than 0.5 ug/kg/min
Show all 12Show fewer
- Pregnant or breastfeeding woman
- Therapeutic limitation with decision of non-reintubation in case of extubation failure
- Non-affiliated or non-beneficiary patient of a social security scheme
- Person deprived of liberty by judicial or administrative decision
- Person under guardianship or curators
- Patient already included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of " Sitting in a Chair " Versus " Conventional Semi-recumbent In-bed Position " on the Oxygenation Level for ICU Non-sedated Patients
The positioning of the ICU patient is a daily concern of the medical and paramedical teams. Developments in emergency medicine and sedation and analgesia techniques have made it possible to reduce patient mortality. However, considered too unstable, patients were no longer mobilized outside the bed until the complete resolution of the symptoms that led to hospitalization or surgery.
Despite encouraging results for early mobilization, bed and rest remained the most widespread positioning technique worldwide with the emergence of intensive care units, mechanical ventilation and sedation/analgesia/curarization. The result is peripheral muscular amyotrophy and respiratory muscular amyotrophy, with increased length of stay and exacerbated morbidity/mortality several years after discharge from ICU.
Read more
Numerous studies have shown the value of early mobilization of the ICU patient to preserve functional and muscular capital.
However, few studies have evaluated the value of mobilizing the ICU patient from the bed in order to improve oxygenation. The lack of mobility outside the bed causes condensation of the pulmonary parenchyma at the bases and in the dorsal region when the patient is lying down or in a prolonged semi-seated position.
In awake spontaneously ventilated patients, whether intubated on ventilatory support (Pressure Support), non-invasive ventilation (NIV) or high flow nasal oxygen therapy (HFNO), the reference position is a semi-seated patient with the head of the resuscitation bed tilted at 30°. The problem with this position in the bed is that patients tend to slide toward the foot of the bed. This migration is due to gravity or the design of the ICU bed. The end result of this migration is that the inclination indicated by the bed head inclinometer does not correspond to the actual angulation between the patient's lower limbs and trunk. The patient finds himself "compressed" in the lower abdomen, which can lead to compression of the diaphragm and thus hypoventilation in the postero-caudal regions of the lungs.
Our hypothesis is that the chair position (outside the ICU bed) allows, without modification of the ventilatory parameters, to improve the alveolar ventilation and thus the oxygenation of the arterial blood, compared to the "natural" semi-seated position in the ICU bed, in patients with spontaneous ventilation (PS/NIV/HFNO).
Read the detailed description
This is a monocentric, comparative, randomized, open-label trial comparing two methods of "seated" positioning of the ICU patient, chair versus natural position in bed, on arterial blood oxygenation
- Sitting in a Chair position For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.
- Semi-recumbent position in bed The patient will benefit from conventional positioning techniques in the ICU bed. With the help of the medical monitoring software present in the wards, we will note the different nursing care given to the patient during the 3 hours following the morning arterial gasometry.
- Conditions
- ICU Patient
- Being tested
- Sitting in chair position
- Keywords
- Bed Rest, Sitting Position, Intensive Care Unit, Semi-recumbent Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting in chair positionProcedure or surgery
For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.
| Study group | Role | What they receive |
|---|---|---|
| Sitting in a chair position | Experimental | For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance. Receives: Procedure: Sitting in chair position |
| Semi-recumbent in bed position | No intervention | The patient will benefit from conventional positioning techniques in the ICU bed. With the help of the medical monitoring software present in the wards, we will note the different nursing care given to the patient during the 3 hours following the morning arterial gasometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the PaO2/FiO2 ratio between arterial gasometry at the end of the night and arterial gasometry at the end of the positioning sequence.
Comparison of the PaO2/FiO2 ratio between early seating out of the bed for ICU patient under spontaneous breathing (NIV/PS/HFNO) and patients in the natural in bed position.
Measured: Hour 3
Secondary outcomes (1)
Incidence of intolerance criteria regarding the randomization group.
The objective is to compare between the two groups the clinical tolerance during positioning
Measured: Hour 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start19 Jun 2020
- Primary completion6 Jul 2024
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ICU PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once the patient is included and the randomization is made, the positioning method will be applied for only one period of 3 hours (if optimal tolerance) and arterial gasometry in relation to the main objective will only be performed on this occasion. For the rest of the stay, the patient will benefit from the usual examinations and positioning techniques in the corresponding ICU.
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FOSSAT, Principal investigator, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446559
- Sponsor's protocol ID
- CHRO-2020-03
- Acronym
- FALCON
- Status last verified
- Aug 2024
- First submitted
- 17 Jun 2020
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Domanski Z, Niezabitowski K, Latawiec-Mazurkiewicz I. [Phlebography of the spermatic vein near the unpalpable testicle]. Rofo. 1980 Sep;133(3):322-4. No abstract available. German.
PubMed 6110624Castellani G, Vincenzi G, Brugnolo E. [Reliability of parapulp support in the coronal reconstruction of silver amalgam in posterior teeth]. Dent Cadmos. 1983 Jun;51(6):25-32. No abstract available. Italian.
PubMed 6583091Fossat G, Muller L, Seguin A, Mathonnet A, Pinos S, Kamel T, Barbier F, Loiseau C, Guemann M, Courtes L, Fossat C, Muller G, Nay MA, Boulain T. Effects of out-of-bed armchair positioning on oxygenation in spontaneously breathing ICU patients receiving respiratory support: a randomized controlled trial. Intensive Care Med. 2026 Jun;52(6):1222-1234. doi: 10.1007/s00134-026-08453-y. Epub 2026 May 18.
PubMed 42149248
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of " Sitting in a Chair " Versus " Conventional Semi-recumbent In-bed Position " on the Oxygenation Level for ICU Non-sedated Patients
- ClinicalTrials.gov ID
- NCT04446559
- Acronym / sponsor ID
- FALCON / CHRO-2020-03
- Conditions
- ICU Patient
- Keywords
- Bed Rest, Sitting Position, Intensive Care Unit, Semi-recumbent Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 6 Jul 2024 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The positioning of the ICU patient is a daily concern of the medical and paramedical teams. Developments in emergency medicine and sedation and analgesia techniques have made it possible to reduce patient mortality. However, considered too unstable, patients were no longer mobilized outside the bed until the complete resolution of the symptoms that led to hospitalization or surgery.
Despite encouraging results for early mobilization, bed and rest remained the most widespread positioning technique worldwide with the emergence of intensive care units, mechanical ventilation and sedation/analgesia/curarization. The result is peripheral muscular amyotrophy and respiratory muscular amyotrophy, with increased length of stay and exacerbated morbidity/mortality several years after discharge from ICU.
Numerous studies have shown the value of early mobilization of the ICU patient to preserve functional and muscular capital.
However, few studies have evaluated the value of mobilizing the ICU patient from the bed in order to improve oxygenation. The lack of mobility outside the bed causes condensation of the pulmonary parenchyma at the bases and in the dorsal region when the patient is lying down or in a prolonged semi-seated position.
In awake spontaneously ventilated patients, whether intubated on ventilatory support (Pressure Support), non-invasive ventilation (NIV) or high flow nasal oxygen therapy (HFNO), the reference position is a semi-seated patient with the head of the resuscitation bed tilted at 30°. The problem with this position in the bed is that patients tend to slide toward the foot of the bed. This migration is due to gravity or the design of the ICU bed. The end result of this migration is that the inclination indicated by the bed head inclinometer does not correspond to the actual angulation between the patient's lower limbs and trunk. The patient finds himself "compressed" in the lower abdomen, which can lead to compression of the diaphragm and thus hypoventilation in the postero-caudal regions of the lungs.
Our hypothesis is that the chair position (outside the ICU bed) allows, without modification of the ventilatory parameters, to improve the alveolar ventilation and thus the oxygenation of the arterial blood, compared to the "natural" semi-seated position in the ICU bed, in patients with spontaneous ventilation (PS/NIV/HFNO).
Detailed description
This is a monocentric, comparative, randomized, open-label trial comparing two methods of "seated" positioning of the ICU patient, chair versus natural position in bed, on arterial blood oxygenation
- Sitting in a Chair position For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.
- Semi-recumbent position in bed The patient will benefit from conventional positioning techniques in the ICU bed. With the help of the medical monitoring software present in the wards, we will note the different nursing care given to the patient during the 3 hours following the morning arterial gasometry.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once the patient is included and the randomization is made, the positioning method will be applied for only one period of 3 hours (if optimal tolerance) and arterial gasometry in relation to the main objective will only be performed on this occasion. For the rest of the stay, the patient will benefit from the usual examinations and positioning techniques in the corresponding ICU.
| Arm | Type | Receives |
|---|---|---|
| Sitting in a chair position | Experimental | Procedure: Sitting in chair positionFor patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance. |
| Semi-recumbent in bed position | No intervention | –The patient will benefit from conventional positioning techniques in the ICU bed. With the help of the medical monitoring software present in the wards, we will note the different nursing care given to the patient during the 3 hours following the morning arterial gasometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥ 18 years old in intensive care unit (ICU) or surgical intensive care unit (SICU)
- Intubated and under mechanical invasive ventilation for at least 24 hours or under non-invasive ventilation for more than 12 hours a day or under continuous high-flow nasal oxygen therapy for more than 24 hours or alternating NIV/HFNO.
- Patient or next of kin who has expressed consent to participate in the study
Key exclusion criteria (12 listed)
- Tracheotomized patient
- Patient with a contraindication to sitting in a chair
- Pregnant or breastfeeding woman
- Therapeutic limitation with decision of non-reintubation in case of extubation failure
- Non-affiliated or non-beneficiary patient of a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitting in chair positionFor patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance. | Procedure or surgery | Sitting in a chair position |
Primary outcome
Evolution of the PaO2/FiO2 ratio between arterial gasometry at the end of the night and arterial gasometry at the end of the positioning sequence.
Time frame: Hour 3
Comparison of the PaO2/FiO2 ratio between early seating out of the bed for ICU patient under spontaneous breathing (NIV/PS/HFNO) and patients in the natural in bed position.
1 secondary outcome
Incidence of intolerance criteria regarding the randomization group.
Time frame: Hour 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 6110624Domanski Z, Niezabitowski K, Latawiec-Mazurkiewicz I. [Phlebography of the spermatic vein near the unpalpable testicle]. Rofo. 1980 Sep;133(3):322-4. No abstract available. German.
- Background: PubMed 6583091Castellani G, Vincenzi G, Brugnolo E. [Reliability of parapulp support in the coronal reconstruction of silver amalgam in posterior teeth]. Dent Cadmos. 1983 Jun;51(6):25-32. No abstract available. Italian.
- Derived from this study: PubMed 42149248Fossat G, Muller L, Seguin A, Mathonnet A, Pinos S, Kamel T, Barbier F, Loiseau C, Guemann M, Courtes L, Fossat C, Muller G, Nay MA, Boulain T. Effects of out-of-bed armchair positioning on oxygenation in spontaneously breathing ICU patients receiving respiratory support: a randomized controlled trial. Intensive Care Med. 2026 Jun;52(6):1222-1234. doi: 10.1007/s00134-026-08453-y. Epub 2026 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume FOSSAT principal investigator
CHR Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting in chair position in people with ICU Patient, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the PaO2/FiO2 ratio between arterial gasometry at the end of the night and arterial gasometry at the end of the positioning sequence. (time frame: Hour 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446559, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.