VITAL: a trial looking at which general anaesthesia technique is better for patient recovery following major non-cardiac surgery
| ISRCTN | ISRCTN62903453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62903453 |
| IRAS number | 297034 |
| Secondary identifying numbers | CPMS 50027, NIHR130573, IRAS 297034 |
- Submission date
- 16/09/2021
- Registration date
- 29/09/2021
- Last edited
- 28/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
More than 1.5 million major non-cardiac surgeries are performed in the NHS each year. In the NHS, general anaesthesia is most often given with an inhaled anaesthetic gas. A commonly used alternative is to give anaesthesia using anaesthetic drugs given into the veins, a technique called total intravenous anaesthesia or TIVA. The two techniques may have important differences in how quickly and how well patients recover.
Many anaesthetists believe TIVA is just as safe as inhalational anaesthesia and provides better and faster recovery after surgery. However, others are not convinced that the benefits of using TIVA outweighs the increased cost of this method of anaesthesia. There is a distinct lack of data describing which method might be better. The VITAL trial will measure the benefits of each technique in terms of patient recovery, survival and safety. The results will ensure that the best method of general anaesthesia is being used in the NHS, so that patients can go home quicker, and with reduced cost for the NHS.
VITAL is a multi-centre pragmatic randomised controlled trial, aiming to test whether TIVA (Total Intravenous Anaesthesia) is superior to inhalational anaesthesia.
Who can participate?
Patients undergoing elective major non-cardiac surgery who are 50 years or over will be eligible to take part in VITAL.
What does the study involve?
Following consent to take part, patients will be randomised to receive either TIVA or inhalational anaesthesia. Patients will then be followed up for 6 months following surgery to see how they’re doing. VITAL are working with another research programme called the Perioperative Quality Improvement Programme (PQIP). PQIP collect data about patient surgeries and use that to inform hospitals how they can improve their surgeries. A lot of the data collected for PQIP will also be used in VITAL.
What are the possible benefits and risks of participating?
You may not benefit directly from taking part in this trial. By allowing us to collect information about the type of anaesthetic used during your surgery and how you recover, we hope to work out which type of anaesthetic is most effective in helping patients recover from surgery and help improve anaesthetic care of patients in the future. As we are comparing two standard practices, we do not anticipate any additional risks by taking part in this study. Anaesthesia is always necessary for anyone undergoing surgery and all anaesthesia carries some risk. Whether you are allocated to inhalational or TIVA general anaesthesia, your safety and care will be our utmost priority. Any additional medication that you may require will always be given such as painkillers, anti-sickness medication. There is the modest time commitment to completing questionnaires. Any answers you give, and data collected will only be used for the purpose of the trial, will be kept strictly confidential and not identify you by name.
Where is the study run from?
University of Warwick (UK)
When is the study starting and how long is it expected to run for?
November 2020 to April 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Joyce Yeung
Dr Shaman Jhanji
VITAL Trial Manager, VITAL@warwick.ac.uk
Contact information
Scientific
Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0003-2950-4758 |
|---|
Scientific
Critical Care Unit
Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
| ORCID ID |
0000-0002-1116-628X |
|---|
Public
Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 522566 |
|---|---|
| VITAL@warwick.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 40436_PIS_v1.0_26May2021.pdf |
| Scientific title | Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: A pragmatic randomised triaL |
| Study acronym | VITAL |
| Study hypothesis | In adult patients (aged ≥50 years) undergoing major non-cardiac surgery, does total intravenous anaesthesia (TIVA) lead to improved patient outcomes compared to inhalational volatile-based anaesthesia? |
| Ethics approval(s) | Approved 30/09/2021, Yorkshire & The Humber – Bradford Leeds Research Ethics Committee ()NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048083; bradfordleeds.rec@hra.nhs.uk), ref: 21/YH/0162 |
| Condition | Total intravenous anaesthesia (TIVA) compared to inhalational volatile-based anaesthesia |
| Intervention | VITAL is a multi-centre pragmatic efficient randomised controlled trial with health economic analysis. A 6-month internal pilot phase will seamlessly run into the main trial, on the condition that the pre-defined success criteria have been met. VITAL will compare the clinical and cost effectiveness of TIVA and inhalational anaesthesia. VITAL will use an efficient trial design led by the Peri-Operative Medicine Clinical Trials Network and partnering with an existing national cohort study hosted by the Royal College of Anaesthetists: the Perioperative Quality Improvement Programme, PQIP. Using PQIP’s prospective clinical dataset and existing NHS data sources, we will limit the burden of research for participants and data collection requirements. VITAL will recruit 2,500 participants across approximately 40 NHS sites in the UK. Participants will be identified during pre-operative assessment clinics and/or theatre lists at participating centres. Participants will be randomly allocated to receive general anaesthetic either intravenously or by inhalation during their surgery. There will be no placebo or blinding. Adults aged 50 and over will be eligible for randomisation if they are undergoing elective major non-cardiac surgery under general anaesthesia (as per the PQIP inclusion criteria) and provide written informed consent to take part. Patients will not be eligible for randomisation if they have any known contraindications to TIVA or inhalational anaesthesia, if a clinician has refused trial entry, if the patient is undergoing a procedure where they are not expected to survive the next 30 days or if the patient has previously participated in VITAL. Patients who cannot provide informed consent or complete trial questionnaires will also be ineligible. VITAL will include a nested pilot in 12 NHS sites, providing the opportunity to run the SWAT (see section below) and pre-determined success criteria (specified in the protocol) will have to be met in order to seamlessly transition into the main trial. Once consented, participants will be randomised using an Interactive Voice Response System (IVRS) to receive either TIVA or inhalational anaesthesia during their surgery. Both methods of anaesthesia will be administered by experienced anaesthetists and delivered according to local guidelines. Data collection will be largely completed via data entry into the PQIP database. We are largely recording clinical data already collected as part of standard care. This includes; surgical and anaesthesia details, recovery data and variables relating to post-operative complications. In addition, participants will be asked to complete questionnaires on Day 1, Day 3, day of discharge, Day 30 and 6 months. These will relate to quality of recovery, quality of life, accidental awareness and health resource use. STUDY WITHIN A TRIAL (SWAT) Within VITAL, a small qualitative study will be undertaken to examine ways of consenting participants into complementary studies. The study will consist of interviews with participants of VITAL, patients who declined to take part in VITAL, and staff members involved in consenting participants into the trial. The study will recruit from 4 NHS Trusts, and will only run during the pilot phase of the VITAL trial. Any findings will be fed into the training and consent process for the main trial. Potential participants of the SWAT will be contacted by a trained qualitative researcher following verbal consent to have their contact details recorded. The researcher will then contact potential participants to provide the SWAT PIS and discuss the study, give them time to ask questions, and if they're happy to proceed, obtain written informed consent to take part in the study. They will then take part in a semi-structured interview exploring their experiences of the consenting process (or if they declined VITAL, the reasons for declining). Interviews may take place in person or over the phone, and will be audio-recorded. The recordings will then be submitted to an external company to provide transcripts, which will be analysised using qualitative methods. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Days alive and at home at 30 days (DAH30) measured using patient records |
| Secondary outcome measures | 1. Days alive and at home at 90 days (DAH90) measured using patient records 2. 30-Day and 90-Day and six-month mortality measured using patient records 3. Quality of recovery after anaesthesia (QoR-15) day 3 post-op 4. Patient satisfaction with anaesthesia (Bauer questionnaire) day 1 post-op. 5. Awareness under anaesthesia measured using the Brice questionnaire day 3 and day 30 post-op. |
| Overall study start date | 01/11/2020 |
| Overall study end date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2,500; UK Sample Size: 2,500 |
| Total final enrolment | 2508 |
| Participant inclusion criteria | 1. Age >=50 years 2. Elective major non-cardiac surgery under general anaesthesia (as per PQIP inclusion criteria) 3. Written informed consent for trial participation |
| Participant exclusion criteria | 1. Known contraindication to either TIVA or inhalational anaesthesia 2. Clinician refusal 3. Procedures where the participant is not expected to survive for 30 days 4. Previous participation in VITAL trial 5. Patient unable to give informed consent or complete questionnaires |
| Recruitment start date | 01/01/2022 |
| Recruitment end date | 10/04/2024 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Chelsea
London
SW3 6JJ
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
London
E1 2ES
United Kingdom
Freeman Road
High Heaton
Newcastle
NE7 7DN
United Kingdom
Torquay
TQ2 7AA
United Kingdom
London
SE5 9RS
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Liverpool
L7 8XP
United Kingdom
Rotherham
S60 2UD
United Kingdom
Stanmore
HA7 4LP
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Taunton
TA1 5DA
United Kingdom
London
E11 1NR
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Croydon
CR7 7YE
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Stockton-on-tees
TS19 8PE
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Newport
NP20 2UB
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Guildford
GU2 7XX
United Kingdom
Uphill
Weston-super-mare
BS23 4TQ
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Clydebank
G81 4DY
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Pontyclun
CF72 8XR
United Kingdom
Bristol
BS2 8HW
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Kilmarnock
KA2 0BE
United Kingdom
London
EC1A 7BE
United Kingdom
Darenth Wood Road
Dartford
DA2 8DA
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
London
SE1 9RT
United Kingdom
Bath
BA1 3NG
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor information
University/education
University of Warwick
Coventry
CV4 7AL
England
United Kingdom
| Phone | +44 (0)24 765 75733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data will be made available to researchers whose full proposal for their use of the data has been approved by the VITAL Trial Management Group and whose research group includes a qualified statistician. Data will be provided after completion of a data sharing agreement. Data sharing agreements would be set up by the Sponsor. Anonymised data will be made available for approved specified purposes only. Requests for data should be made to VITAL@warwick.ac.uk. Start date: 2 years after publication of the main study results End date: 5 years after publication of the main study results |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 26/05/2021 | 27/09/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 4.0 | 10/08/2023 | 01/11/2023 | No | Yes |
| Protocol article | 27/06/2024 | 28/06/2024 | Yes | No |
Additional files
Editorial Notes
28/06/2024: Publication reference added.
14/05/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/05/2024 to 10/04/2024.
2. Total final enrolment added.
01/11/2023: The following changes were made:
1. Study public contact updated.
2. Patient information sheet v4.0 uploaded.
3. The recruitment start date was changed from 01/11/2021 to 01/01/2022.
4. The recruitment end date was changed from 01/11/2024 to 31/05/2024.
5. The following study participating centres were added: Barking, Havering and Redbridge University Hospitals NHS Trust, Rotherham District Hospital, Royal National Orthopaedic Hospital, Leeds Teaching Hospitals NHS Trust, St George's University Hospitals NHS Foundation Trust, Musgrove Park Hospital, Whipps Cross Hospital, James Cook University Hospital, Addenbrookes, Queen Elizabeth Hospital, Croydon University Hospital, Milton Keynes University Hospital, University Hospital of North Tees, Yeovil District Hospital NHS Foundation Trust, Royal Gwent Hospital, Pinderfields General Hospital, Morriston Hospital, Royal Surrey County Hospital, Weston General Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, University Hospital of Wales, Golden Jubilee National Hospital, Manchester University NHS Foundation Trust, Great Western Hospitals NHS Foundation Trust, The Royal Glamorgan Hospital, Bristol Royal Infirmary, Salford Royal Hospital, University Hospital Crosshouse, St. Bartholomews Hospital, Dartford and Gravesham NHS Trust, Sunderland Royal Hospital, Oxford University Hospitals NHS Foundation Trust, Guy's & St Thomas Hospital, Royal United Hospitals Bath NHS Foundation Trust, and Nottingham University Hospitals NHS Trust.
6. The Christie Hospital study participating centre was removed.
04/10/2021: The ethics approval has been updated to include the approval date.
16/09/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
