Acute Respiratory Failure With HypoxiaPhase 3RESTNCT02654327
pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
A Phase 3 study testing VV-ECCO2R to enable lower tidal volume mechanical ventilation in people with Acute Respiratory Failure With Hypoxia, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia
- What is being tested?
- VV-ECCO2R to enable lower tidal volume mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2016to 30 Apr 2022
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation using positive end expiratory pressure (PEEP) ≥ 5cmH2O
- Acute and potentially reversible cause of acute respiratory failure as determined by the treating physician
- Within 48 hours of the onset of hypoxemia as defined by Pa02/Fi02 less than or equal to 20kPA
Who cannot join
- Age < 16 years old
- Intubated and mechanically ventilated via an endotracheal or tracheostomy tube ≥ 7 days (168 hours) up to the time of randomisation
- Ability to maintain Vt to ≤ 3ml/kg PBW while maintaining pH ≥ 7.2 as determined by the treating physician
- Receiving, or decision to commence, ECMO in the next 24 hours
- Mechanical ventilation using high frequency oscillation ventilation or airway pressure release ventilation
- Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of acute respiratory failure
Show all 19Show fewer
- Acute respiratory failure fully explained by left ventricular failure or fluid overload (May be determined by clinical assessment or echocardiography/cardiac output monitoring)
- Left ventricular failure requiring mechanical support
- Contra-indication to limited systemic anticoagulation with heparin
- Unable to obtain vascular access to a central vein (internal jugular or femoral vein)
- Consent declined
- Treatment withdrawal imminent within 24 hours
- Patients not expected to survive 90 days on basis of premorbid health status
- DNAR (Do Not Attempt Resuscitation) order (excluding advance directives) in place
- Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
- Severe chronic liver disease (Child Pugh >11)
- Platelet count < 40,000 mm3 (Prior to catheter insertion)
- Previously enrolled in the REST trial
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure
Read the detailed description
Acute hypoxaemic respiratory failure requiring mechanical ventilation is a major cause of morbidity and mortality. A significant proportion of affected patients will have the Acute Respiratory Distress Syndrome (ARDS). Mechanical ventilation is often required to provide adequate gas exchange and although it is life-saving in this setting, it is also now known to contribute to the morbidity and mortality in the condition. Ventilators delivering high pressures and volumes cause regional over distension in the injured lung resulting in further inflammation and non-cardiogenic pulmonary oedema. The release of inflammatory mediators from the damaged lung causes systemic inflammation leading to multi-organ failure and death.
The few interventions that have been shown to reduce the high mortality in these patients have targeted ventilator-induced lung injury (VILI). A landmark trial by the ARDSNet trials group found that ventilating patients with acute hypoxaemic respiratory failure secondary to ARDS with a lung protective strategy aiming for a reduced tidal volume of 6ml/kg predicted body weight (PBW) and a maximum end-inspiratory plateau pressure (Pplat) ≤ 30cmH2O decreased mortality from 40% (in the conventional arm treated with tidal volume less than 12ml/kg PBW) to 31%.
Extracorporeal carbon dioxide removal (ECCO2R) in association with mechanical ventilation offers a potentially attractive solution to permit tidal volume reduction to less than 6ml/kg PBW and to achieve low plateau pressures (< 25cmH2O). Using these extracorporeal circuits, carbon dioxide can be 'dialysed' out of the blood while the lungs are ventilated in a more protective manner. In recent years, more efficient veno-venous devices have become available. These have replaced arterio-venous devices and have the advantage of not requiring arterial puncture. These can achieve carbon dioxide removal with relatively low extracorporeal blood flows (0.4-1 l/min) requiring only a smaller dual lumen venous catheter. In addition these ECCO2R devices use more biocompatible materials making the device more resistant to clot formation and cause less platelet and clotting factor consumption. Therefore only minimal systemic anticoagulation is required which reduces the likelihood of bleeding complications. These devices are now comparable to renal dialysis equipment, which is routinely used safely as standard care in ICUs in the United Kingdom.
Together this highlights the need for a large randomised controlled trial to establish whether VV-ECCO2R in acute hypoxaemic respiratory failure can allow the use of a more protective ventilatory strategy and is associated with improved patient outcomes. Importantly, if there was no benefit, the trial would provide evidence to stop the widespread adoption of an expensive and ineffective or potentially harmful treatment in this setting.
- Conditions
- Acute Respiratory Failure With Hypoxia
- Being tested
- VV-ECCO2R to enable lower tidal volume mechanical ventilation
- Keywords
- Extracorporeal, Acute Respiratory Distress Syndrome, Protective Lung Ventilation, Ventilator Induced Lung Injury, Carbon Dioxide Removal, Lung, Lung Injury
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV-ECCO2R to enable lower tidal volume mechanical ventilationDevice
In the intervention arm a dual lumen catheter will be inserted into a central vein. VV-ECCO2R is commenced and managed as per study manual. Tidal volumes are then reduced on mechanical ventilation to enable lower tidal volume ventilation. Lower tidal volume facilitated by VV-ECCO2R will continue for a least 2 days up to a maximum of 7 days
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard care with conventional lung protective mechanical ventilation |
| ECCO2R to enable lower tidal volume mechanical ventilation | Experimental | VV-ECCO2R to enable lower tidal volume mechanical ventilation (target tidal volume of ≤ 3ml/kg predicted body weight and a Pplat ≤ 25cmH20) Receives: Device: VV-ECCO2R to enable lower tidal volume mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 90 days after randomisation
Secondary outcomes (12)
Tidal volume (ml/kg Predicted Body Weight)
Measured: day 2 and day 3 after randomisation
Ventilator free days
Measured: 28 days after randomisation
Duration of ventilation in survivors
Measured: 28 days after randomisation
Need for Extracorporeal Membrane Oxygenation (ECMO)
Measured: 7 days after randomisation
Mortality rate
Measured: 28 days, 6 months and 1 year after randomisation
Health Related Quality of Life
Measured: 6 months and 1 year after randomisation
Adverse Event Rate
Measured: 28 days
Health & Social Care Service costs
Measured: 6 months and 1 year after randomisation
St George Respiratory Questionnaire
Measured: 1 year after randomisation
Need for home oxygen
Measured: 6 months and 1 year after randomisation
Post Traumatic Stress Syndrome Questionnaire (PTSS-14)
Measured: 1 year after randomisation
Montreal Cognitive Assessment (MoCA-BLIND) or AD8 Dementia Screening Interview (AD8)
Measured: 1 year after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start12 May 2016
- Primary completion12 Mar 2020
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure With HypoxiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, Northern Ireland Clinical Trials Unit
- Responsible party
- Principal investigator, Professor Danny McAuley, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654327
- Sponsor's protocol ID
- 15084DMcA-AS
- Other IDs
- 13/143/02
- Acronym
- REST
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Fitzgerald M, Millar J, Blackwood B, Davies A, Brett SJ, McAuley DF, McNamee JJ. Extracorporeal carbon dioxide removal for patients with acute respiratory failure secondary to the acute respiratory distress syndrome: a systematic review. Crit Care. 2014 May 15;18(3):222. doi: 10.1186/cc13875.
PubMed 25033302Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
PubMed 19741487Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
PubMed 23306584Boyle AJ, Reddy K, Conlon J, Auzinger G, Bannard-Smith J, Barrett NA, Camporota L, Gillies MA, Jackson C, McDowell C, Patel B, Perkins GD, Szakmany T, Tunnicliffe W, Welters ID, McNamee JJ, McAuley DF, O'Kane CM. Evaluation of Plasma Biomarkers to Understand the Biology and Heterogeneity of Treatment Effect in Lower Tidal Volume Ventilation Facilitated by Extracorporeal CO2 Removal in Acute Hypoxemic Respiratory Failure: A Secondary Analysis of the REST Trial. Crit Care Explor. 2025 Mar 27;7(4):e1246. doi: 10.1097/CCE.0000000000001246. eCollection 2025 Apr 1.
PubMed 40146037Agus A, McNamee JJ, Jackson C, McAuley DF. Extracorporeal carbon dioxide removal compared to ventilation alone in patients with acute hypoxaemic respiratory failure: cost-utility analysis of the REST RCT. Health Technol Assess. 2023 Aug;29(33):1-34. doi: 10.3310/FCDQ8036.
PubMed 37843629Boyle AJ, McDowell C, Agus A, Logan D, Stewart JD, Jackson C, Mills J, McNamee JJ, McAuley DF. Acute hypoxaemic respiratory failure after treatment with lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal: long-term outcomes from the REST randomised trial. Thorax. 2023 Aug;78(8):767-774. doi: 10.1136/thorax-2022-218874. Epub 2022 Oct 5.
PubMed 36198573McNamee JJ, Gillies MA, Barrett NA, Perkins GD, Tunnicliffe W, Young D, Bentley A, Harrison DA, Brodie D, Boyle AJ, Millar JE, Szakmany T, Bannard-Smith J, Tully RP, Agus A, McDowell C, Jackson C, McAuley DF; REST Investigators. Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure: The REST Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1013-1023. doi: 10.1001/jama.2021.13374.
PubMed 34463700Stokes JW, Gannon WD, Rice TW. Extracorporeal Carbon Dioxide Removal or Extracorporeal Membrane Oxygenation: Why Should We Care? Crit Care Med. 2021 May 1;49(5):e546-e547. doi: 10.1097/CCM.0000000000004844. No abstract available.
PubMed 33854019
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
- ClinicalTrials.gov ID
- NCT02654327
- Acronym / sponsor ID
- REST / 15084DMcA-AS
- Conditions
- Acute Respiratory Failure With Hypoxia
- Keywords
- Extracorporeal, Acute Respiratory Distress Syndrome, Protective Lung Ventilation, Ventilator Induced Lung Injury, Carbon Dioxide Removal, Lung, Lung Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, Northern Ireland Clinical Trials Unit
- Study start
- 12 May 2016 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- 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.
This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure
Detailed description
Acute hypoxaemic respiratory failure requiring mechanical ventilation is a major cause of morbidity and mortality. A significant proportion of affected patients will have the Acute Respiratory Distress Syndrome (ARDS). Mechanical ventilation is often required to provide adequate gas exchange and although it is life-saving in this setting, it is also now known to contribute to the morbidity and mortality in the condition. Ventilators delivering high pressures and volumes cause regional over distension in the injured lung resulting in further inflammation and non-cardiogenic pulmonary oedema. The release of inflammatory mediators from the damaged lung causes systemic inflammation leading to multi-organ failure and death.
The few interventions that have been shown to reduce the high mortality in these patients have targeted ventilator-induced lung injury (VILI). A landmark trial by the ARDSNet trials group found that ventilating patients with acute hypoxaemic respiratory failure secondary to ARDS with a lung protective strategy aiming for a reduced tidal volume of 6ml/kg predicted body weight (PBW) and a maximum end-inspiratory plateau pressure (Pplat) ≤ 30cmH2O decreased mortality from 40% (in the conventional arm treated with tidal volume less than 12ml/kg PBW) to 31%.
Extracorporeal carbon dioxide removal (ECCO2R) in association with mechanical ventilation offers a potentially attractive solution to permit tidal volume reduction to less than 6ml/kg PBW and to achieve low plateau pressures (< 25cmH2O). Using these extracorporeal circuits, carbon dioxide can be 'dialysed' out of the blood while the lungs are ventilated in a more protective manner. In recent years, more efficient veno-venous devices have become available. These have replaced arterio-venous devices and have the advantage of not requiring arterial puncture. These can achieve carbon dioxide removal with relatively low extracorporeal blood flows (0.4-1 l/min) requiring only a smaller dual lumen venous catheter. In addition these ECCO2R devices use more biocompatible materials making the device more resistant to clot formation and cause less platelet and clotting factor consumption. Therefore only minimal systemic anticoagulation is required which reduces the likelihood of bleeding complications. These devices are now comparable to renal dialysis equipment, which is routinely used safely as standard care in ICUs in the United Kingdom.
Together this highlights the need for a large randomised controlled trial to establish whether VV-ECCO2R in acute hypoxaemic respiratory failure can allow the use of a more protective ventilatory strategy and is associated with improved patient outcomes. Importantly, if there was no benefit, the trial would provide evidence to stop the widespread adoption of an expensive and ineffective or potentially harmful treatment in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard care with conventional lung protective mechanical ventilation |
| ECCO2R to enable lower tidal volume mechanical ventilation | Experimental | Device: VV-ECCO2R to enable lower tidal volume mechanical ventilationVV-ECCO2R to enable lower tidal volume mechanical ventilation (target tidal volume of ≤ 3ml/kg predicted body weight and a Pplat ≤ 25cmH20) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Invasive mechanical ventilation using positive end expiratory pressure (PEEP) ≥ 5cmH2O
- Acute and potentially reversible cause of acute respiratory failure as determined by the treating physician
- Within 48 hours of the onset of hypoxemia as defined by Pa02/Fi02 less than or equal to 20kPA
Key exclusion criteria (19 listed)
- Age < 16 years old
- Intubated and mechanically ventilated via an endotracheal or tracheostomy tube ≥ 7 days (168 hours) up to the time of randomisation
- Ability to maintain Vt to ≤ 3ml/kg PBW while maintaining pH ≥ 7.2 as determined by the treating physician
- Receiving, or decision to commence, ECMO in the next 24 hours
- Mechanical ventilation using high frequency oscillation ventilation or airway pressure release ventilation
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 |
|---|---|---|
| VV-ECCO2R to enable lower tidal volume mechanical ventilationIn the intervention arm a dual lumen catheter will be inserted into a central vein. VV-ECCO2R is commenced and managed as per study manual. Tidal volumes are then reduced on mechanical ventilation to enable lower tidal volume ventilation. Lower tidal volume facilitated by VV-ECCO2R will continue for a least 2 days up to a maximum of 7 days | Device | ECCO2R to enable lower tidal volume mechanical ventilation |
Primary outcome
All cause mortality
Time frame: 90 days after randomisation
12 secondary outcomes
Tidal volume (ml/kg Predicted Body Weight)
Time frame: day 2 and day 3 after randomisation
Ventilator free days
Time frame: 28 days after randomisation
Duration of ventilation in survivors
Time frame: 28 days after randomisation
Need for Extracorporeal Membrane Oxygenation (ECMO)
Time frame: 7 days after randomisation
Mortality rate
Time frame: 28 days, 6 months and 1 year after randomisation
Health Related Quality of Life
Time frame: 6 months and 1 year after randomisation
Adverse Event Rate
Time frame: 28 days
Health & Social Care Service costs
Time frame: 6 months and 1 year after randomisation
St George Respiratory Questionnaire
Time frame: 1 year after randomisation
Need for home oxygen
Time frame: 6 months and 1 year after randomisation
Post Traumatic Stress Syndrome Questionnaire (PTSS-14)
Time frame: 1 year after randomisation
Montreal Cognitive Assessment (MoCA-BLIND) or AD8 Dementia Screening Interview (AD8)
Time frame: 1 year after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 25033302Fitzgerald M, Millar J, Blackwood B, Davies A, Brett SJ, McAuley DF, McNamee JJ. Extracorporeal carbon dioxide removal for patients with acute respiratory failure secondary to the acute respiratory distress syndrome: a systematic review. Crit Care. 2014 May 15;18(3):222. doi: 10.1186/cc13875.
- Background: PubMed 19741487Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
- Background: PubMed 23306584Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
- Derived from this study: PubMed 40146037Boyle AJ, Reddy K, Conlon J, Auzinger G, Bannard-Smith J, Barrett NA, Camporota L, Gillies MA, Jackson C, McDowell C, Patel B, Perkins GD, Szakmany T, Tunnicliffe W, Welters ID, McNamee JJ, McAuley DF, O'Kane CM. Evaluation of Plasma Biomarkers to Understand the Biology and Heterogeneity of Treatment Effect in Lower Tidal Volume Ventilation Facilitated by Extracorporeal CO2 Removal in Acute Hypoxemic Respiratory Failure: A Secondary Analysis of the REST Trial. Crit Care Explor. 2025 Mar 27;7(4):e1246. doi: 10.1097/CCE.0000000000001246. eCollection 2025 Apr 1.
- Derived from this study: PubMed 37843629Agus A, McNamee JJ, Jackson C, McAuley DF. Extracorporeal carbon dioxide removal compared to ventilation alone in patients with acute hypoxaemic respiratory failure: cost-utility analysis of the REST RCT. Health Technol Assess. 2023 Aug;29(33):1-34. doi: 10.3310/FCDQ8036.
- Derived from this study: PubMed 36198573Boyle AJ, McDowell C, Agus A, Logan D, Stewart JD, Jackson C, Mills J, McNamee JJ, McAuley DF. Acute hypoxaemic respiratory failure after treatment with lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal: long-term outcomes from the REST randomised trial. Thorax. 2023 Aug;78(8):767-774. doi: 10.1136/thorax-2022-218874. Epub 2022 Oct 5.
- Derived from this study: PubMed 34463700McNamee JJ, Gillies MA, Barrett NA, Perkins GD, Tunnicliffe W, Young D, Bentley A, Harrison DA, Brodie D, Boyle AJ, Millar JE, Szakmany T, Bannard-Smith J, Tully RP, Agus A, McDowell C, Jackson C, McAuley DF; REST Investigators. Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure: The REST Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1013-1023. doi: 10.1001/jama.2021.13374.
- Derived from this study: PubMed 33854019Stokes JW, Gannon WD, Rice TW. Extracorporeal Carbon Dioxide Removal or Extracorporeal Membrane Oxygenation: Why Should We Care? Crit Care Med. 2021 May 1;49(5):e546-e547. doi: 10.1097/CCM.0000000000004844. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VV-ECCO2R to enable lower tidal volume mechanical ventilation in people with Acute Respiratory Failure With Hypoxia, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 19 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
All cause mortality (time frame: 90 days after randomisation). 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 NCT02654327, which also lists 9 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 Mar 2022.