Analysing Gastric Residual Volumes in Infants Fed With Breast Milk 3 Hours Prior to General Anaesthesia
Conditions: Gastric Residual Volume
Sponsor: King's College Hospital NHS Trust

 
 
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Short Title 
Reducing fasting time for breast milk to 3 hours 
 
Full Title 
A prospective interventional study analysing gastric residual volumes in infants fed with breast milk 3 hours 
prior to general anaesthesia  
 
 
 
Chief Investigator 
Dr Emily Saffer 
e-mail:  Emily.saffer@nhs.net 
tel:  07890549924 
Sponsor(s) 
 
 
Jasmine Paimer 
 Research & Development Governance Manager 
King’s College Hospital NHS Foundation Trust 
The R&D Office 
First Floor Coldharbour Works 
245A Coldharbour Lane 
Brixton 
London SW9 8RR 
 
 
 
Funder (s): 
Anaesthetic Department, King’s College Hospital 
IRAS Reference 
314367 
 
 
 
 
 
 
 
 
Protocol Version 6.0 30th April 2024 
 
 

 
 
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CONTENTS 
1 
INTRODUCTION 
8 
2 
BACKGROUND AND RATIONALE 
8 
3 
OBJECTIVES 
8 
3.1 
Primary Objective
 
8 
3.2 
Secondary Objectives
 
8 
4 
STUDY DESIGN 
8 
5 
STUDY SCHEDULE 
8 
6 
CONSENT 
9 
7 
ELIGIBILITY CRITERIA 
9 
7.1 
Inclusion Criteria
 
9 
7.2 
Exclusion Criteria
 
9 
8 
RECRUITMENT 
9 
9 
STATISTICAL METHODS 
9 
10 
PATIENT AND PUBLIC INVOLVEMENT (PPI) 
9 
11 
FUNDING AND SUPPLY OF EQUIPMENT 
9 
12 
DATA HANDLING AND MANAGEMENT 
10 
13 
MATERIAL/SAMPLE STORAGE 
10 
14 
PEER AND REGULATORY REVIEW 
10 
15 
ADVERSE EVENTS AND INCIDENT REPORTING 
11 
15.1 
Definitions of Adverse Events
 
11 
15.2 
Assessments of Adverse Events
 
11 
 
Severity
 
11 
Causality 
12 
15.3 
Procedures for recording adverse events
 
13 

 
 
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15.4 
Procedures for recording and reporting Serious Adverse Events
 
13 
15.5 
Serious Adverse Events that do not require reporting
 
13 
15.6 
Reporting Urgent Safety Measures
 
14 
15.7 
Protocol deviations and notification of protocol violations
 
14 
15.8 
Trust incidents and near misses
 
16 
16 
MONITORING AND AUDITING 
16 
17 
TRAINING 
16 
18 
INTELLECTUAL PROPERTY 
16 
19 
INDEMNITY ARRANGEMENTS 
17 
20 
ARCHIVING 
17 
21 
PUBLICATION AND DISSEMINATION POLICY 
17 
22 
REFERENCES 
18 
23 
APPENDICES 
18 
 
 
KEY WORDS 
Fasting 
Anaesthesia 
Children 
Breastfeeding 
Gastric 
 
LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
CAG 
Confidential Advisory Group 
CI 
Chief Investigator 
CRF 
Case Report Form 
GE 
Gastric emptying 
GAfREC 
Governance Arrangement for NHS Research Ethics 
HRA 
Health Research Authority 
HTA 
Human Tissue Authority 
ICF 
Informed Consent Form 

 
 
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PI 
Principal Investigator 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification 
GRV 
Gastric residual volume 
TMF 
Trial Master File 
 
 
 

 
 
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STUDY SUMMARY 
STUDY OVERVIEW 
Full title 
A prospective interventional study analysing gastric residual volumes and 
young children fed with breast milk 3 hours prior to general anaesthesia  
 
Objectives 
Measurement of volume of gastric contents for babies fed with breast milk 3 
hours prior to general anaesthesia 
 
Correlation of gastric volume as estimated by ultrasound, with actual 
volume of gastric contents aspirated under anaesthesia 
 
Feasibility study for larger trial assessing gastric contents for babies fed 
formula milk 4 or 6 hours prior to general anaesthesia. 
Type of trial 
A prospective, interventional study of 60 term children aged 37 weeks to 18 
months, undergoing elective surgery 
Trial design and methods 
 
The aim of this study is to ascertain the pH and Gastric residual volume (GRV) 
of gastric contents in 60 young children who are breast fed 3 hours prior to 
general anaesthesia. The secondary aim of this study is to ascertain how well 
ultrasound (USS) derived measurement of GRV, using the gastric antrum cross 
sectional area (ACSA), correlates to direct measurement via aspiration. 
Findings of this study will inform the design of a larger randomised controlled 
trial assessing GRV in infants fed 4 or 6 hours prior to general anaesthesia. 
 
Following Research Ethical Committee approval and registration on 
clinicaltrials.gov, recruitment is estimated to begin in September 2022. 
 
We will perform a prospective, interventional study of 60 term young children 
aged 37 weeks post menstrual age to 18 months, undergoing elective surgery 
at Kings’ College Hospital and Birmingham Women and Childrens’ Hospital. 
 
Parents who have provided consent to participate will be asked to begin their 
final breast feed 3 hours prior to anticipated procedure time. Parents will be 
asked to feed as normal until satiety, and record start and finish times. 
Parents using expressed breast milk (EBM) will be included, and given the 
same instructions. They will also be asked to note down the volume of EBM 
given. 
  
Prior to anaesthesia, a gastric ultrasound (USS) will be performed in the 
lateral decubitus position, and gastric antrum cross sectional area (ACSA) will 
be recorded. Once asleep and following securement of the airway, an 
orogastric tube will be inserted into the stomach. Any gastric contents will be 
aspirated and volume will be recorded. In the event that a child becomes 
distressed during the USS examination, the study investigator may defer 
completion of the scan until after induction of general anaesthesia. 
 
Health condition(s) or 
problem(s) studied 
Gastric emptying in term young children undergoing elective surgery 
Target sample size 
60 
Trial duration per 
participant: 
24 hours 

 
 
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Main inclusion/exclusion 
criteria: 
Inclusion criteria 
Babies born after 37 weeks post menstrual age, and upto 18 months of age 
Babies born prior to 37 weeks gestation, who are now greater than 37 weeks 
corrected post menstrual age 
Elective surgery 
 
Exclusion criteria 
Previous surgery to stomach or upper gastrointestinal tract 
Liver, heart or kidney diseases 
Diabetes 
Being born prior to 37 weeks gestation who are now greater than 37 weeks 
post menstrual age, but with significant lung, cardiac or neurological 
comorbidity. 
Severe lung diseases that mean they use oxygen or a ventilator at home 
Previous involvement in this research study, less than 28 days prior.  
 
Statistical methodology 
and analysis: 
 
Categorical variables will be analysed by Chi-squared or Fisher’s exact 
test as appropriate. Continuous variables will be tested for normality 
of distribution then analysed by t-test or Mann Whitney U test as 
appropriate. 
 
The sample size of 60 would allow the estimation of a recruitment rate of 60%, 
within a 95% confidence interval of +/-10%.  
STUDY TIMELINES 
Study Duration/length 
2 years 
Expected Start Date 
September 2022 
End of Study definition and 
anticipated date 
End of recruitment, anticipated to be September 2024 
Key Study milestones  
 
Submission to REC May 2022 
Preparation of CRF and training for PIs and study team July-August 
2022 
First patient recruitment September 2022 at KCH 
First patient recruitment November 2023 at BWC 
STORAGE of SAMPLES  
(if applicable) 
Human tissue samples 
N/A 
Data collected / Storage 
Any gastric contents aspirated from a participant will be measured for 
volume and then disposed of immediately. 
 
 
 
 
 
 
 
 
 
 

 
 
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1 INTRODUCTION 
The detrimental effects of prolonged fasting in young children prior to general anaesthesia (GA) are well 
known, and include thirst and dehydration, hunger, low blood sugar and acidosis at induction of anaesthesia.  
The aim of this study is to ascertain the gastric residual volume (GRV) of gastric contents in 100 infants who 
are breast fed 3 hours prior to general anaesthesia. The secondary aim of this study is to ascertain how well 
ultrasound (USS) derived measurement of GRV, using the gastric antrum cross sectional area (ACSA), correlates 
to direct measurement via aspiration. 
It is anticipated that demonstrating that there is minimal gastric residual volume after a 3 hour fast will add to 
a body of evidence in support of reducing fasting times for breast feeding in children.  
 
BACKGROUND AND RATIONALE 
Current UK guidance recommends a fasting time of 4 hours for breast milk prior to general anaesthesia. 
European guidance has recently changed, advocating a 3 hour fast for breast milk. Some tertiary centres in the 
UK have already adopted this change, 
Gastric emptying (GE) of breast milk and formula preparations has been extensively studied in neonatal 
intensive care settings for preterm and low birth weight infants, in order to establish optimum feeding 
regimens for growth. Breast milk has been demonstrated to empty from the stomach in an exponential 
manner, with gastric ultrasound studies illustrating that antrum measurements return to baseline (pre feed 
measurements) within 3 hours.  Methodologies utilised in such studies can make applying findings to current 
routine anaesthetic practice difficult: Such as inclusion of very low birth weight infants, use of fortified breast 
milk, administering feeds via nasogastric tube, and using gastric ultrasound to estimate GRV, rather than direct 
measurement of volume, for example by naso-gastric tube,  Animal studies have illustrated that severe lung 
injury occurs when volumes of acidified milk above 0.8ml/kg are instilled into the trachea. 
There is a paucity of evidence in breast fed, un-premedicated term babies/infants subjected to a 3 hour fast 
prior to GA, where GRV is measured directly. 
Pulmonary aspiration is known to be a rare event associated with lower morbidity and mortality in children 
than in adults . In animal studies, instillation of acidic solutions at pH1 are associated with increasing severity 
of lung injury as volume of solution increases above 0.8ml/kg of pH 1. A small single centre study conducted in 
Australia in 30 premature babies reported GRV following 3 hourly nasogastric tube feeds of breast milk. 83% of 
babies had an empty stomach at 3 hours, and of those with some milk left behind, the mean GRV was 
0.4ml/kg.  a child or adult with a full stomach is more hazardous and requires alteration of the anaesthetic 
technique to minimise risk of aspiration. Gastric ultrasound (USS) is a useful tool for assessing stomach volume 
prior to induction of anaesthesia. Various formulae have been devised to convert measured gastric antral area 
to predicted gastric residual volume in children. USS is validated in older children and adults in measurement 
of gastric ACSA and derived volume of gastric contents. To date there is no ‘safe cut off’ value for residual 

 
 
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volume of breast milk in babies, prior to anaesthesia. For fasted adults, where any residual volume is likely to 
be acidic clear fluid, a volume of 1.5ml/kg has been advocated. A much lower value of 0.8ml/kg has been 
advocated in this study, based on evidence from animal studies, the main difference being that partially 
digested milk in the stomach will be particulate in nature. If the predicted volume on ultrasound is greater 
than this, surgery will be deferred, cancelled, or a modified anaesthetic technique used. 
 
2 OBJECTIVES 
2.1 Primary Objective  
The primary aim of this study is to ascertain the GRV of gastric contents in 100 infants who are breast fed 3 
hours prior to general anaesthesia.  
 
2.2 Secondary Objectives  
The secondary aim of this study is to ascertain how well ultrasound (USS) derived measurement of GRV, using 
the gastric antrum cross sectional area (ACSA), correlates to direct measurement via aspiration. 
 
2.3 Tertiary Objectives 
The final objective of this study is to inform the design of a larger randomised controlled trial assessing GRV in 
infants who are formula fed, either 4 or 6 hours prior to a feed. This study will be hosted by King’s College 
Hospital, and will use similar methodology to screen and recruit patients. 
 
3 STUDY DESIGN 
● 
We will perform a prospective, interventional study of 60 term children aged 37 weeks PMA to 18 
months, undergoing elective surgery at KCH and BWC. A minimum sample size of 35 was calculated 
for a non-inferiority margin of 0.2 ml/kg, based upon a standard deviation of 0.76 ml/kg for gastric 
residual volume with 90% power and a significance level of 0.05. A sample size of 30.9 was calculated 
to be necessary. This was increased to 35 to allow for a 10% dropout rate. Calculations were 
performed in the TrialSize package in R. Expanding the sample size to 60 at two NHS sites will increase 
the impact of our findings and will be adequate to inform the larger study in terms of recruitment rate 
. 
● 
Approximate duration of enrolment is 2 years.  
● Categorical variables will be analysed by Chi-squared or Fisher’s exact test as appropriate. 
Continuous variables will be tested for normality of distribution then analysed by t-test or 
Mann Whitney U test as appropriate. 
 
 
 

 
 
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4 STUDY SCHEDULE 
 
All children are routinely assessed in a virtual or face to face clinic prior to planned surgery (so called 
pre-assessment). This assessment is carried out by a consultant anaesthetist or nurse. As part of the 
pre-assessment process, parents are asked if they would be willing to be contacted about research 
projects. If confirmed, the study team will contact the parent/guardian prior to the planned surgery 
date to discuss eligibility and give information about the study.  
 
The consent process will take place either around the time of pre-assessment verbally over video 
link or telephone, and confirmed with written consent on the day of surgery or for in-patients, the 
day before surgery. For those who have consented to take part, the study team will confirm 
eligibility as necessary using the child’s electronic patient record. 
 
Following recruitment, all children will be followed up for the first 24 hours following the 
intervention. Any adverse events will be recorded. Participants may withdraw from the study at any 
time. Parents will be kept informed of any relevant events or findings occurring from admission to 
the ward through to discharge home that are felt to be relevant to the study. 
 
The study enrolment will cease when the 100 children have been recruited. The study will be 
terminated prematurely if there is any unexpected serious adverse event 

 
 
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Table 1: Schedule of Assessments 
 
 
 
Pre assessment  
Pre operative visit 
Anaesthetic room 
Operating theatre 
Post operative visit 
Visit No 
1 
2 
3 
4 
5 
Window of flexibility for 
timing of visits: 
e.g +/- 2 weeks 
1 hour 
20 minutes 
5 minutes 
24 hours 
 
Informed Consent 
X (verbal) 
X (written) 
 
 
 
Medical History 
x 
 
 
 
 
Physical Examination 
 
 
 
 
X if applicable 
Vital Signs 
 
x 
 
 
X if applicable 
Eligibility confirmation 
 
x 
 
 
 
Trial specific 
interventions 
 
 
 
Routine interventions 
 
 
USS examination 
 
 
 
 
Routine checks as per 
WHO checklist 
 
GRV of gastric contents 
USS examination under 
general anaesthesia, if 
not completed awake 
 
 
General anaesthesia 
Surgery 
 

 
 
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Adverse Events Review 
 
 
 
x 
x 
Concomitant 
Medication Review (if 
applicable) 
x 
x 
 
 
 

 
 
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5 CONSENT 
Eligible participants will be identified at the time of the pre-assessment clinic (usually a virtual meeting 
between a consultant anaesthetist or nurse and the parent/guardian of a child, upto 4 weeks prior to 
surgery).  During this process all patients and parents are asked if they consent to being contacted for 
research purposes. 
 
Parents/guardians who give consent to being approached by the study team at the time of pre 
assessment, will be contacted within the 4 weeks prior to planned surgery to discuss eligibility and 
receive information regarding the study. 
 
The consent process will take place either around the time of pre-assessment verbally over video link 
or telephone, and confirmed with written consent on the day of surgery, or for in-patients on the day 
before surgery. 
 
Non English speakers will not be eligible for inclusion. As the study population are children upto 1 year 
of age, the consent process will involve communication with parents/guardians only.  
 
 
6 ELIGIBILITY CRITERIA 
Inclusion Criteria 
 
Babies born after 37 weeks post menstrual age, and upto 18 months of age 
Babies born prior to 37 weeks gestation, who are now greater than 37 weeks post-menstrual age on the day of 
surgery 
Elective surgery 
 
Exclusion Criteria 
ASA score of 4 or above (American Society of Anaesthesiologists' physical status classification system) 
Emergency surgery 
Known or suspected gastro-intestinal disease or hepato-biliary disease including varices and strictures within 
the upper gastro-intestinal tract 
Gastro‐oesophageal reflux disease (GORD): either on treatment or under investigation), 
liver or renal failure, 
oesophageal achalasia, 
diabetes mellitus with gastroparesis, 

 
 
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Previous surgery which may alter gastric emptying or anatomy of oesophagus, stomach or small intestine 
Anticipated difficult airway 
Concomitant administration of any other medication orally prior to anaesthesia, but excluding sedative pre-
medication eg midazolam 
Bleeding disorder 
Prematurity (defined as a child born earlier than 37 weeks gestation, who is less than 37 weeks post menstrual 
age on the day of surgery) 
Chronic lung disease requiring home oxygen or any form of non-invasive ventilation, including optiflow. 
Patients taking antacids or pro-kinetic drugs, or requiring them pre-operatively 
Patients taking immunosuppressive medication 
Children or household members with symptoms suggestive of current or recent SARS-Cov-2 (covid 19) 
infection 
Children or household members with a recent RT-PCR positive swab result for SARS-Cov-2 
Children under 60 weeks corrected gestational age whose mother had a RT-PCR positive swab in the third 
trimester of pregnancy 
Children already recruited into this research study within the last 28 days. 
 
7 PATIENT AND PUBLIC INVOLVEMENT (PPI) 
We are planning to interview 20 sets of parents who are currently breast feeding their children. We 
will use this opportunity to check instructions we give to recruited families are clear, easy to 
understand and realistic to achieve. 
 
8 FUNDING AND SUPPLY OF EQUIPMENT  
The study funding has been reviewed by the KCH R&I Office, and deemed sufficient to cover the 
requirements of the study. The study will be reviewed by R&I at BWC and the same process will be 
followed there. 
 
This study does not require any external funding. All equipment to be used is available for routine care 
of children undergoing general anaesthesia. We have confirmation from the Clinical Director for 
Anaesthetics and Theatres at KCH and BWC, that any small costs (estimated upto £160) incurred for 
consumables, will be covered by the department.  
 
 
 
 

 
 
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DATA HANDLING AND MANAGEMENT 
 
Paper consent sheets and CRFs will be pseudonymised and held in a locked office within the 
anaesthetics department. Electronic data will also be pseudonymised prior to storage on the CI’s 
password protected Trust computer. Statistical analysis will be performed by Dr Nielsen, a 
Consultant Anaesthetist at Cambridge University Hospitals NHS Trust. Only this pseudonymised data 
will be shared with Dr Nielsen via nhs mail.  
 
9 MATERIAL/SAMPLE STORAGE  
Any gastric fluid aspirated from a patient will be measured for volume and acidity and then 
immediately disposed of. 
 
10 PEER AND REGULATORY REVIEW 
The study has been peer reviewed in accordance with the requirements outlined by KCH R&I.  
 
This study has been peer reviewed within KCH by an independent and relevant peer review committee 
on 23rd March 2022. The Sponsor has accepted these reviews as adequate evidence of peer review.  
The study has been reviewed by R&D at BWC and confirmation obtained that BWC has the capacity 
and capability to deliver the study. 
 
The study was deemed to require regulatory approval from the following bodies (list). Each 
approval will be obtained before the study commences.  
● HRA 
● REC 
11 ADVERSE EVENTS AND INCIDENT REPORTING 
 
11.1 Definitions of Adverse Events  
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or study participant, 
which does not necessarily have a causal relationship with the 
intervention/treatment/procedure involved.  
Serious Adverse Event 
(SAE). 
Any adverse event that: 
● 
results in death, 
● 
is life-threatening*, 
● 
requires hospitalisation or prolongation of existing 
hospitalisation**, 
● 
results in persistent or significant disability or incapacity, or 
● 
consists of a congenital anomaly or birth defect 

 
 
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*A life- threatening event, this refers to an event in which the participant was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have caused death 
if it were more severe. 
** Hospitalisation is defined as an in-patient admission, regardless of length of stay. 
Hospitalisation for pre-existing conditions, including elective procedures do not constitute an SAE. 
16.2 
Assessments of Adverse Events  
Each adverse event will be assessed for severity, causality, seriousness and expectedness as described 
below. 
Severity  
Category 
Definition 
Mild 
The adverse event does not interfere with the participant’s daily routine, and does 
not require further procedure; it causes slight discomfort 
Moderate 
The adverse event interferes with some aspects of the participant’s routine, or 
requires further  procedure, but is not damaging to health; it causes moderate 
discomfort 
Severe 
The adverse event results in alteration, discomfort or disability which is clearly 
damaging to health 
 
 
Causality 
The assessment of relationship of adverse events to the procedure is a clinical decision based on all 
available information at the time of the completion of the case report form.   
The following categories will be used to define the causality of the adverse event: 
Category 
Definition 
Definitely: 
There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. 
Probably: 
There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely 
Possibly 
There is some evidence to suggest a causal relationship (e.g. the event occurred 
within a reasonable time after administration of the study procedure). However, 
the influence of other factors may have contributed to the event (e.g. the 
participant’s clinical condition, other concomitant events). 

 
 
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Unlikely 
There is little evidence to suggest there is a causal relationship (e.g. the event did 
not occur within a reasonable time after administration of the study procedure). 
There is another reasonable explanation for the event (e.g. the participant’s 
clinical condition). 
Not related 
There is no evidence of any causal relationship. 
Not Assessable 
Unable to assess on information available. 
 
Expectedness 
Category 
Definition 
Expected 
An adverse event which is consistent with the available information about the 
intervention/treatment/procedure in use in this study.   
Unexpected 
An adverse event which is not consistent with the available information about the 
intervention/treatment/procedure in use in this study* 
* this includes listed events that are more frequently reported or more severe than previously 
reported 
16.3 Procedures for recording adverse events  
All adverse events will be recorded with clinical symptoms and accompanied with a simple, brief 
description of the event, including dates as appropriate.  
16.4 Procedures for recording and reporting Serious Adverse Events  
All serious adverse events will be recorded in the medical records and the CRF.   
All SAEs will also  be recorded on a serious adverse event (SAE) form. The CI/PI or designated individual 
will complete an SAE form and the form will be emailed to the R&I Office (kch-
tr.researchqualityassurance@nhs.net) within 1 working day of becoming aware of the event.  
Where the event is unexpected and thought to be related to the intervention/treatment/procedure 
this will be reported by the Investigator to the REC and Health Research Authority, using the SAE 
Report form for non-CTIMPs (available from the HRA website) within 15 days.   
Premature termination of the study 
The study may be prematurely discontinued by the Sponsor, CI or HRA on the basis of new safety 
information, for example if the participants have a statistically significant increased incidence of 
serious adverse events compared with published literature, or if the study team were to have other 
safety concerns at any time. IF the trial is discontinued, active participants will be informed and no 
further participant data will be collected. The Competent Authority and REC will be informed within 
15 days of the early termination of the study. 
 

 
 
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16.6 Reporting Urgent Safety Measures  
If any urgent safety measures are taken the CI/ PI shall immediately and in any event no later than 3 
days from the date the measures are taken, give written notice to the relevant REC, Health Research 
Authority and R&I office of the measures taken and the circumstances giving rise to those measures. 
16.5 Protocol deviations and notification of protocol violations 
A deviation is usually an unintended departure from the expected conduct of the study protocol/SOPs, 
which does not need to be reported to the sponsor.   The CI will monitor protocol deviations. 
 
 A protocol violation is a breach which is likely to effect to a significant degree – 
(a) the safety or physical or mental integrity of the participants of the study; or 
(b) the scientific value of the study. 
The CI and R&I Office should be notified immediately of any case where the above definition applies 
during the study conduct phase.  

 
 
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Flow Chart for SAE reporting  
AE occurs 
Assign Severity Grade 
Was the event Serious? 
No 
Yes 
Yes 
No 
Submit SAE form to: 
{for single site studies- KCH R&I Office) 
{for multisite studies – CI/Trial Manager/ Research 
Nurse} 
S
i hi 5
ki
d
Record in medical records,  
and CRF in accordance with the protocol  
 
Record in medical records 
and CRF 
Is the event specified as an adverse event which does not require immediate reporting as an SAE?  
See section 15.5.  
Record in medical records, CRF  
Complete an SAE report form 
{Include for multisite 
studies- Submit SAE form 
to KCH R&I office} 
 

 
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16.6 Trust incidents and near misses 
An incident or near miss is any unintended or unexpected event that could have or did lead to harm, 
loss or damage that contains one or more of the following components: 
a. It is an accident or other incident which results in injury or ill health. 
b. It is contrary to specified or expected standard of patient care or service. 
c. It places patients, staff members, visitors, contractors or members of the public at 
unnecessary risk. 
d. It puts the Trust in an adverse position with potential loss of reputation. 
e. It puts Trust property or assets in an adverse position or at risk. 
Incidents and near misses must be reported to the Trust through DATIX as soon as the individual 
becomes aware of them. 
A reportable incident is any unintended or unexpected event that could have or did lead to harm, loss 
or damage that contains one or more of the following components: 
 
a) It is an accident or other incident which results in injury or ill health. 
b) It is contrary to specified or expected standard of patient care or service. 
c) It places patients, staff members, visitors, contractors or members of the public at 
unnecessary risk. 
d) It puts the Trust in an adverse position with potential loss of reputation. 
e) It puts Trust property or assets in an adverse position or at risk of loss or damage. 
17 MONITORING AND AUDITING 
The Chief Investigator will ensure there are adequate quality and number of monitoring activities 
conducted by the study team. This will include adherence to the protocol, procedures for consenting 
and ensure adequate data quality.  
 
The Chief Investigator will inform the sponsor should he/she have concerns which have arisen from 
monitoring activities, and/or if there are problems with oversight/monitoring procedures. 
 
18 TRAINING 
The Chief Investigator will review and provide assurances of the training and experience of all staff 
working on this study.  Appropriate training records will be maintained in the study files 
 
All members of the study team will have a recent (within 2 years) certificate for completion of the 
Good Clinical Practice course. All team members are employed as substantive consultants or registrars 
in training posts in anaesthesia at KCH. All team members will be trained in using the CRF, pH meter 
and performance of gastric USS, and will have received mandatory Trust training in data protection 
and GDPR .  
 
INTELLECTUAL PROPERTYINDEMNITY ARRANGEMENTS 
 
KCH will provide NHS indemnity cover for negligent harm, as appropriate and is not in the position to 
indemnify for non-negligent harm. NHS indemnity arrangements do not extend to non-negligent harm 
and NHS bodies cannot purchase commercial insurance for this purpose; it cannot give advance 
undertaking to pay compensation when there is no negligence attributable to their vicarious liability. 
The Trust will only extend NHS indemnity cover for negligent harm to its employees, both substantive 
and honorary, conducting research studies that have been approved by the R&D Department. The 

 
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Trust cannot accept liability for any activity that has not been properly registered and Trust approved. 
Potential claims should be reported immediately to the R&I Office 
 
19 ARCHIVING 
Pseudonymised data will be archived for 25 years: Paper CRFs will be stored in a locked office within 
the anaesthetic department and electronic data will be stored on the CI’s password protected Trust 
PC.  
20 PUBLICATION AND DISSEMINATION POLICY 
Findings of the study will be submitted for publication in a relevant peer reviewed scientific journal. 
Findings may also be shared at a relevant national or international conference.  
 
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