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Trial registered on ANZCTR


Registration number
ACTRN12617000609358
Ethics application status
Approved
Date submitted
20/04/2017
Date registered
28/04/2017
Date last updated
28/01/2020
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Normal saline instillation and lung recruitment with paediatric endotracheal suction
Scientific title
Feasibility of normal saline instillation and lung recruitment with paediatric endotracheal suction: A pilot, factorial, randomised controlled trial
Secondary ID [1] 290071 0
Nil known
Universal Trial Number (UTN)
U1111-1187-1340
Trial acronym
NARES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endotracheal suction 300140 0
mechanically ventilated children 302935 0
ventilator associated pneumonia 302936 0
Condition category
Condition code
Respiratory 302414 302414 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Normal saline instillation - 0.1ml per kg
Lung recruitment manoeuvre - 2x baseline PEEP setting (max 18) for 2 minutes

Endotracheal suction will be performed when clinically indicated and as per standard practice. Patients will be mechanically ventilated using a pressure regulated volume control mode.

Group 1 (No NSI and No LR): ETS will be performed by the PICU clinician as clinically indicated and as per standard practice. No NSI and no LR is to be used.

Group 2 (No NSI and LR): ETS will be performed by the PICU clinician as clinically indicated and as per standard practice. No normal saline is to be instilled during the ETS episode. For LR - at the completion of the ETS episode, the patient will be reconnected to the ventilator and the baseline PEEP setting will be doubled (to a maximum of 18 cmH2O for two minutes.

Group 3 (NSI and No LR): ETS will be performed by the PICU clinician as clinically indicated and as per standard practice. Upon disconnection of the patient from 0.1ml/kg of normal saline will be instilled directly into the ETT before connecting the anaesthetic bag and proceeding with the ETS procedure. On completion of the ETS procedure the patient will be reconnected to the ventilator. Ventilator settings will not change from baseline.

Group 4 (NSI and LR): ETS will be performed by the PICU clinician as clinically indicated and as per standard practice. Upon disconnection of the patient from the ventilator 0.1ml/kg of normal saline will be instilled directly into the ETT before connecting the anaesthetic bag and proceeding with the ETS procedure. For LR at the completion of the ETS episode, the patient will be reconnected to the ventilator and the baseline PEEP setting will be doubled (to a maximum of 18 cmH2O) for two minutes.

Strategies to promote intervention fidelity
Study Design
1. Standardised treatment dose for all patients (0.1ml/kg/ double PEEP)
2. Experiment timeframe 48hrs only

Training providers
3. Standardised interventionist training
4. Study education manual
5. Education resources on PICU data sharing site for bedside clinicians to refer to
6. Face to face education sessions

Monitoring intervention fidelity
7. Work reminders will appear on a worklist on the PICU clinical information system. Clinicians have to sign the task on completion. .
8. CI or a Clinical Research Nurse will be visible on the clinical floor and visit nurses, patients and families who are enrolled.
9. The CI will conduct monthly reviews of protocol adherence and feed back to clinicians in monthly leadership meetings and via staff emails.
Intervention code [1] 295801 0
Treatment: Other
Comparator / control treatment
No normal saline instillation
No lung recruitment manoeuvre
Control group
Active

Outcomes
Primary outcome [1] 299543 0
Feasibility
Composite primary outcome
Feasibility assessment will include:
a) Eligibility: 75% of patients screened are eligible
b) Recruitment: 70% of eligible patients are recruited
c) Retention: Less than 15% of patients withdraw or are lost to follow-up
d) Protocol Adherence: 80% of participants will receive their allocated treatment throughout their study participation
e) Missing data: There will be less than 10% missing data
Timepoint [1] 299543 0
End of trial
Secondary outcome [1] 327478 0
Sp02/Fi02
Timepoint [1] 327478 0
Sp02 will be collected and stored on the bedside monitor (Phillips) and clinical information system MetaVision (iMDsoft).

Fi02 will be recorded and stored on a breath to breath basis with a bellavista 1000 (imtmedical) mechanical ventilator

Data will be collected in all patients at the same time points including: Baseline (pre-endotracheal suction), post endotracheal suction, 2 minutes post ETS (post LR if applicable) and 10 minutes post endotracheal suction
Secondary outcome [2] 334128 0
Lung compliance
Timepoint [2] 334128 0
Dynamic lung compliance will be measured and stored on a breath to breath basis with a bellavista 1000 (imtmedical) mechanical ventilator.

Data will be collected in all patients at the same time points including: baseline (pre-endotracheal suction), post endotracheal suction, 2 minutes post ETS (post LR if applicable), 10 minutes post endotracheal suction and hourly for 48 hours
Secondary outcome [3] 334130 0
Ventilator associated pneumonia
Review of medical record. Clinically defined pneumonia will be confirmed using the United States Centres for Disease Control and Prevention algorithm for clinically defined pneumonia. For VAP referred to as clinically defined pneumonia (PNU) (three categories PNU1, PNU2 and PNU 3) to be confirmed both clinical and radiology criteria need to be fulfilled.
Timepoint [3] 334130 0
Diagnosis during ICU admission.
Incidence per 1000 ventilator days
Secondary outcome [4] 334131 0
End expiratory level (EEL)
Timepoint [4] 334131 0
End expiratory level will be measured continuously during the endotracheal suction episode using electrical impedance tomography (EIT).

EIT measurements will be performed once per day during study enrollment. All measurements will be performed in all patients at the same time points including: baseline (pre-endotracheal suction), post-endotracheal suction, 2 minutes post ETS (post LR if applicable) and 10 minutes post endotracheal suction.
Secondary outcome [5] 334132 0
Regional tidal volume
Timepoint [5] 334132 0
Regional tidal volume will be measured continuously during the endotracheal suction episode using electrical impedance tomography (EIT).

EIT measurements will be performed once per day during study enrollment. All measurements will be performed in all patients at the same time points including: baseline (pre-endotracheal suction), post endotracheal suction, 2 minutes post ETS (post LR if applicable) and 10 minutes post endotracheal suction,

Eligibility
Key inclusion criteria
1. 0 (>37weeks gestation) – 16 years of age (15 years + 364 days)
2. Oral or nasal endotracheal tube
3. Conventional mechanical ventilation using volume control mode (PRVC)
4. Likely to be ventilated for >24hours
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cardiac surgery in this admission
2. Air leak syndrome*
3. Ventilated for >48hrs prior to screening
4. Previous study enrolment in this hospital admission
5. Current diagnosis of ventilator associated pneumonia
6. Tracheal reconstruction
7. Cystic fibrosis
8. Pulmonary hypoplasia
9. Traumatic brain injury or raised intracranial pressure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Web based randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur twice (once for each intervention pair) and be generated on a 1:1 ratio between groups as per a computer generated randomisation schedule. Randomisation will be stratified by reason for intubation (respiratory vs non respiratory), with randomly varied block sizes (4 and 6) within each stratum.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
To promote protocol adherence, the experiment time frame for the both interventions will be 48hrs after enrolment into the study.

Lung recruitment will be assessed using electrical impedance tomography.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As the pilot trial is not powered to detect statistical significance, statistical analysis will be used for piloting purposes only. Comparability of groups at baseline will be assessed using clinical parameters and reported using descriptive statistics. Mean and standard deviation will be used to report normally distributed continuous data, median and interquartile range will be used for interval data that cannot be approximated with a normal distribution. The primary outcome measure of feasibility will be reported descriptively, against predefined criteria using frequency (percentages) for categorical data. Incidence rates of VAP per 1000 ventilator days and 95% confidence intervals will be calculated using Poisson regression. For secondary outcomes measured using interval data (Sp02/Fi02, Cdyn, EEL, VT), linear regressions will be run in a pairwise sequential manner; with assessment of a possible interaction effect. The primary analyses will be undertaken on an intention-to-treat basis. Data will be analysed using IBM SPSS Statistics Version 22. An alpha value of 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2017
Actual
16/10/2017
Date of last participant enrolment
Anticipated
31/07/2019
Actual
17/10/2019
Date of last data collection
Anticipated
30/08/2019
Actual
17/10/2019
Sample size
Target
100
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7772 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 14239 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 294468 0
Government body
Name [1] 294468 0
Children's Health Queensland Study, Education and Trust Account Committee
Country [1] 294468 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Rd, Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 293334 0
Hospital
Name [1] 293334 0
Lady Cilento Children's Hospital
Address [1] 293334 0
501 Stanley Street South Brisbane, Queensland 4101
Country [1] 293334 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295899 0
Childrens Health Queensland Human Research Ethics Committee
Ethics committee address [1] 295899 0
Ethics committee country [1] 295899 0
Australia
Date submitted for ethics approval [1] 295899 0
27/11/2016
Approval date [1] 295899 0
22/12/2016
Ethics approval number [1] 295899 0
HREC/16/GRCH/374
Ethics committee name [2] 295900 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 295900 0
Ethics committee country [2] 295900 0
Australia
Date submitted for ethics approval [2] 295900 0
01/01/2017
Approval date [2] 295900 0
01/02/2017
Ethics approval number [2] 295900 0
2017/065

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68762 0
Ms Jessica Schults
Address 68762 0
Lady Cilento Children's Hospital
Level 4a Paediatric Intensive Care Unit
501 Stanley Street South Brisbane, QLD 4101
Country 68762 0
Australia
Phone 68762 0
+61 7 3069 7563
Fax 68762 0
Email 68762 0
[email protected]
Contact person for public queries
Name 68763 0
Jessica Schults
Address 68763 0
Lady Cilento Children's Hospital
Level 4a Paediatric Intensive Care Unit
501 Stanley Street South Brisbane, QLD 4101
Country 68763 0
Australia
Phone 68763 0
+61 7 3069 7563
Fax 68763 0
Email 68763 0
[email protected]
Contact person for scientific queries
Name 68764 0
Jessica Schults
Address 68764 0
Lady Cilento Children's Hospital
Level 4a Paediatric Intensive Care Unit
501 Stanley Street South Brisbane, QLD 4101
Country 68764 0
Australia
Phone 68764 0
+61 7 3069 7563
Fax 68764 0
Email 68764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data is confidential


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1879Study protocol    https://bmjopen.bmj.com/content/8/1/e019789



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNormal saline instillation versus no normal saline instillation and lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction: The NARES trial. A study protocol for a pilot, factorial randomised controlled trial.2018https://dx.doi.org/10.1136/bmjopen-2017-019789
N.B. These documents automatically identified may not have been verified by the study sponsor.