Physiological ShockG-FORCENCT04586374
G- Forces On Retrieved ChildrEn Pilot Study
An observational study of Physiological Shock, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
G-Forces On Retrieved ChildrEn (Pilot) Study is a feasibility study looking at the effect of G-Forces in vivo during episodes of paediatric critical care transport. The study aims to (i) understand the relationship between the physics of transport on physiological parameters and (ii) assess whether syringe driver… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Physiological Shock
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2021to 31 Aug 2023
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Any child, 36 weeks corrected gestation to 18 years, accepted for transport by the COMET retrieval service
Who may be able to join
- Any child, 36 weeks corrected gestation to 18 years, accepted for transport by the COMET retrieval service who has an arterial line with active arterial blood pressure monitoring at departure from the referring hospital. The decision for the need for an arterial line is determined purely on a clinical basis by the referring, transporting or accepting clinical team.
Who cannot join
- Children outside the specified age range.
- Children who do not have invasive arterial blood pressure monitoring during a transport episode.
- Any case where patients, parents or guardians elect to opt out of data analysis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
G-Forces On Retrieved ChildrEn (Pilot) Study is a feasibility study looking at the effect of G-Forces in vivo during episodes of paediatric critical care transport. The study aims to (i) understand the relationship between the physics of transport on physiological parameters and (ii) assess whether syringe driver delivery (previously demonstrated to be affected by G-forces in vitro), is responsible for physiological variations in transported paediatric patients requiring vasoactive/inotropic infusions.
Read the detailed description
Throughout the UK, paediatric transport services are responsible for the stabilisation and transport of critically unwell children. This involves moving children from district general hospitals to receive specialist care in tertiary centres and moving children between tertiary and quaternary centres in order to provide the appropriate level of specialist care.
Critically unwell children often require infusions of essential, life-saving medications during episodes of transport. Disruption of these infusions can be destabilising and even life-threatening. Examples of essential infusions include the use of prostin in duct-dependent congenital heart disease, vasoactive/inotropic medications in shock and sedation and muscle relaxants to ensure comfortable, safe transfer.
Critically unwell patients often require support in the form of inotropes/vasopressors to support cardiac contractility and alter vascular tone and are commonly used in the treatment of shock. Physiological response to vasoactive/inotropic drugs is rapid and measurable in terms of cardiovascular status through observing changes in heart rate, blood pressure and oxygenation of peripheral tissues (pulse oximetry). As such these medications offer the potential to observe whether syringe driver delivery variations as mediated through the effect of g-forces exert measurable physiological instability in transported patients.
G-Forces Pilot is a prospective, observational, case-control, feasibility study investigating the effect of G-forces as measured by an accelerometer against physiological parameters of heart rate, invasive blood pressure measurement and oxygen saturations in vivo during episodes of transport. The study aims to understand the relationship between the physics of transport on physiological parameters and to assess whether syringe driver delivery (previously demonstrated to be affected by G-forces in-vitro), is responsible for physiological variations in transported patients requiring vasoactive/inotropic infusions.
The investigators propose to examine this relationship by obtaining and analysing data on physiological parameters in patients during episodes of transport to assess:
(i) Whether G-forces experienced by being in a moving ambulance affect the stability of patient physiological parameters.
(ii) How variations in syringe driver delivery mediated through the effects of G-Forces affect patients in transit as evidenced through instability in physiological parameters whilst receiving vasoactive/inotropic infusions.
This will be examined by the comparison of a control and study group. The control group will consist of patients with full monitoring (including an arterial line), without vasoactive/inotropic support. The study group will consist of patients with full monitoring (including an arterial line) receiving vasoactive/inotropic support through a syringe driver. Data analysis will assess the strength of correlation between patient observations and experienced g-forces recorded during the episode of transport to answer the study question.
- Conditions
- Physiological Shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Transported patients with full monitoring (including an arterial line), without inotropic/vasoactive support. | |
| Study Group | Transported patients with full monitoring and vasoactive/inotropic support being delivered by a syringe driver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between physiological parameters and G-forces during transport episode
Beat to beat, wave-form data from physiological parameters of heart rate, oxygen saturations and invasive arterial blood pressure measured during transport will provide a set of continuous data outputs. Calculating the correlation coefficient will indicate the strength of relationship between physiological parameters and the experienced G-forces with the aim of answering two questions:
- Do G-forces (the acceleration and deceleration forces) experienced by being in a moving ambulance, affect the stability of patient observations - heart rate, blood pressure and oxygen saturations.
- Do G-forces experienced by being in a moving ambulance, affect the delivery of vasoactive/inotropic drug infusions which in turn affects the stability of observations.
Measured: 12 months study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start4 Mar 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ShockStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Shires, BMBS BMedSci, Study chair, NUH, NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586374
- Sponsor's protocol ID
- 20CS032
- Acronym
- G-FORCE
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G- Forces On Retrieved ChildrEn Pilot Study
- ClinicalTrials.gov ID
- NCT04586374
- Acronym / sponsor ID
- G-FORCE / 20CS032
- Conditions
- Physiological Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Oct 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.
G-Forces On Retrieved ChildrEn (Pilot) Study is a feasibility study looking at the effect of G-Forces in vivo during episodes of paediatric critical care transport. The study aims to (i) understand the relationship between the physics of transport on physiological parameters and (ii) assess whether syringe driver delivery (previously demonstrated to be affected by G-forces in vitro), is responsible for physiological variations in transported paediatric patients requiring vasoactive/inotropic infusions.
Detailed description
Throughout the UK, paediatric transport services are responsible for the stabilisation and transport of critically unwell children. This involves moving children from district general hospitals to receive specialist care in tertiary centres and moving children between tertiary and quaternary centres in order to provide the appropriate level of specialist care.
Critically unwell children often require infusions of essential, life-saving medications during episodes of transport. Disruption of these infusions can be destabilising and even life-threatening. Examples of essential infusions include the use of prostin in duct-dependent congenital heart disease, vasoactive/inotropic medications in shock and sedation and muscle relaxants to ensure comfortable, safe transfer.
Critically unwell patients often require support in the form of inotropes/vasopressors to support cardiac contractility and alter vascular tone and are commonly used in the treatment of shock. Physiological response to vasoactive/inotropic drugs is rapid and measurable in terms of cardiovascular status through observing changes in heart rate, blood pressure and oxygenation of peripheral tissues (pulse oximetry). As such these medications offer the potential to observe whether syringe driver delivery variations as mediated through the effect of g-forces exert measurable physiological instability in transported patients.
G-Forces Pilot is a prospective, observational, case-control, feasibility study investigating the effect of G-forces as measured by an accelerometer against physiological parameters of heart rate, invasive blood pressure measurement and oxygen saturations in vivo during episodes of transport. The study aims to understand the relationship between the physics of transport on physiological parameters and to assess whether syringe driver delivery (previously demonstrated to be affected by G-forces in-vitro), is responsible for physiological variations in transported patients requiring vasoactive/inotropic infusions.
The investigators propose to examine this relationship by obtaining and analysing data on physiological parameters in patients during episodes of transport to assess:
(i) Whether G-forces experienced by being in a moving ambulance affect the stability of patient physiological parameters.
(ii) How variations in syringe driver delivery mediated through the effects of G-Forces affect patients in transit as evidenced through instability in physiological parameters whilst receiving vasoactive/inotropic infusions.
This will be examined by the comparison of a control and study group. The control group will consist of patients with full monitoring (including an arterial line), without vasoactive/inotropic support. The study group will consist of patients with full monitoring (including an arterial line) receiving vasoactive/inotropic support through a syringe driver. Data analysis will assess the strength of correlation between patient observations and experienced g-forces recorded during the episode of transport to answer the study question.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Transported patients with full monitoring (including an arterial line), without inotropic/vasoactive support. |
| Study Group | – | –Transported patients with full monitoring and vasoactive/inotropic support being delivered by a syringe driver. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any child, 36 weeks corrected gestation to 18 years, accepted for transport by the COMET retrieval service
Key inclusion criteria (1 listed)
- Any child, 36 weeks corrected gestation to 18 years, accepted for transport by the COMET retrieval service who has an arterial line with active arterial blood pressure monitoring at departure from the referring hospital. The decision for the need for an arterial line is determined purely on a clinical basis by the referring, transporting or accepting clinical team.
Key exclusion criteria (3 listed)
- Children outside the specified age range.
- Children who do not have invasive arterial blood pressure monitoring during a transport episode.
- Any case where patients, parents or guardians elect to opt out of data analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between physiological parameters and G-forces during transport episode
Time frame: 12 months study period
Beat to beat, wave-form data from physiological parameters of heart rate, oxygen saturations and invasive arterial blood pressure measured during transport will provide a set of continuous data outputs. Calculating the correlation coefficient will indicate the strength of relationship between physiological parameters and the experienced G-forces with the aim of answering two questions: 1. Do G-forces (the acceleration and deceleration forces) experienced by being in a moving ambulance, affect the stability of patient observations - heart rate, blood pressure and oxygen saturations. 2. Do G-forces experienced by being in a moving ambulance, affect the delivery of vasoactive/inotropic drug infusions which in turn affects the stability of observations.
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 22 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Physiological Shock
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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.
Peter Shires, BMBS BMedSci study chair
NUH, NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiological Shock, run by Nottingham University Hospitals NHS 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 1 inclusion and 3 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 22 Dec 2025. 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.
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?
Correlation between physiological parameters and G-forces during transport episode (time frame: 12 months study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.