ANZCTR - Registration

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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]

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

mechanically ventilated children

ventilator associated pneumonia

Condition category

Condition code

Respiratory

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]

Treatment: Other

Comparator / control treatment

No normal saline instillation
No lung recruitment manoeuvre

Control group

Active

Outcomes

Primary outcome [1]

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]

End of trial

Secondary outcome [1]

Sp02/Fi02

Timepoint [1]

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]

Lung compliance

Timepoint [2]

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]

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]

Diagnosis during ICU admission.
Incidence per 1000 ventilator days

Secondary outcome [4]

End expiratory level (EEL)

Timepoint [4]

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]

Regional tidal volume

Timepoint [5]

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?

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

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Lady Cilento Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Children's Health Queensland Study, Education and Trust Account Committee

Address [1]

Lady Cilento CHildren's Hospital
Children's Health Queensland Hospital and Health Service
501 Stanley Street
South Brisbane, QLD, 4101

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Rd, Nathan QLD 4111

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Lady Cilento Children's Hospital

Address [1]

501 Stanley Street South Brisbane, Queensland 4101

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Childrens Health Queensland Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/11/2016

Approval date [1]

22/12/2016

Ethics approval number [1]

HREC/16/GRCH/374

Ethics committee name [2]

Griffith University Human Research Ethics Committee

Ethics committee address [2]

170 Kessels Rd, Nathan QLD 4111

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/01/2017

Approval date [2]

01/02/2017

Ethics approval number [2]

2017/065

Summary

Brief summary

In the presence of a critical illness a child may require mechanical ventilation to support their breathing.  In the intensive care unit this is achieved through the insertion of an endotracheal tube.  This tube serves as the child’s airway and is cared for by a nurse.  The nurse removes mucous from the tube by performing an endotracheal suction (ETS).  Saline is often used with ETS.  Saline use is thought to help loosen dried mucous and prevent it from blocking the tube.  Researchers have shown suction is important to prevent complications which arise from retained airway mucous, however, there is no quality research regarding saline use with suction to help guide nurses ETS practice.  

ETS is associated with a number of complications including pulmonary derecruitment.  Collapsed alveolar negatively impair gas exchange and may be colonised by bacteria leading to nosocomial infection and ventilator associated pneumonia.   The use of lung recruitment following ETS may help to restore pulmonary volumes and prevent harmful,  accumulative atelectasis.  

We will compare ETS in mechanically ventilated children with i) normal saline instillation (NSI) and no NSI and ii) lung recruitment (LR) and no LR.  The primary outcome is trial feasibility as determined by a composite analysis of recruitment, retention, protocol adherance and missing data.  Secondary outcomes include measures of gas exchange, respiratory mechanics and ventilator associated pneumonia.  

Research examining ETS best nursing practice is lacking. Leaving nurses to make ETS related decisions in a vacuum of evidence.  These decisions can influence the outcomes of critically ill children.  Conducting research in paediatric populations is challenging and piloting trial protocols prior to committing the resources needed for a definitive trial helps maximise the efficiency of the trial and processes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Jessica Schults

Address

Lady Cilento Children's Hospital
Level 4a Paediatric Intensive Care Unit
501 Stanley Street South Brisbane, QLD 4101

Country

Australia

Phone

+61 7 3069 7563

Fax

[email protected]

Contact person for public queries

Name

Jessica Schults

Address

Lady Cilento Children's Hospital
Level 4a Paediatric Intensive Care Unit
501 Stanley Street South Brisbane, QLD 4101

Country

Australia

Phone

+61 7 3069 7563

Fax

[email protected]

Contact person for scientific queries

Name

Jessica Schults

Address

Lady Cilento Children's Hospital
Level 4a Paediatric Intensive Care Unit
501 Stanley Street South Brisbane, QLD 4101

Country

Australia

Phone

+61 7 3069 7563

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Participant data is confidential

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1879	Study 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

Source	Title	Year of Publication	DOI
Embase	Normal 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.	2018	https://dx.doi.org/10.1136/bmjopen-2017-019789

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically