ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000432819

Ethics application status

Approved

Date submitted

16/04/2012

Date registered

17/04/2012

Date last updated

17/04/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of saline instillation during physiotherapy (SIP) in the intensive care unit - a randomized crossover trial

Scientific title

Saline instillation during physiotherapy in intubated patients and the effect on sputum volume

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1130-0169

Trial acronym

Saline Instillation during Physiotherapy (SIP)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critically ill intubated intensive care patients

Condition category

Condition code

Infection

Other infectious diseases

Injuries and Accidents

Other injuries and accidents

Injuries and Accidents

Burns

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Instillation of 2mls Sodium Chloride isotonic solution 0.9% into the artificial airway via the lavage port prior to physiotherapy treatment. Those allocated to group A will receive saline instillation prior to suction during physiotherapy on day one, day two no saline will be used. The reverse will happen for those patients allocated to group B. There will be a washout period of 24 hours between interventions.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No instillation of fluid prior to physiotherapy treatment

Control group

Active

Outcomes

Primary outcome [1]

Secretions will be collected in a sputum trap (Tyco Healthcare Kendall Argyle) attached to the closed suction system. The freeze dried weight will be measured

Timepoint [1]

Immediately at the end of intervention

Secondary outcome [1]

Airway resistance (Raw) cm H2O/L/second
This measure will be derived from the mechanical ventilator.

Timepoint [1]

Before and immediately after the intervention

Secondary outcome [2]

PaO2/FiO2 or Oxygenation ratio
This indicates the ratio of the oxygenation of the patient relative to the amount of inspired oxygen they are receiving. It is calculated by dividing the PaO2 (as measured by an arterial blood gas) by the fraction of inspired oxygen (from the ventilator).Two mls of arterial blood will be taken from the arterial line by a heparized syringe and analysed using a benchtop Arterial Blood Gas Analyser (ABL 700 Series gas Machines, RADIOMETER, Copenhagen, Denmark).

Timepoint [2]

An arterial blood gas will be taken immediately pre, post and 60 minutes post intervention.

Secondary outcome [3]

Haemodynamics: blood pressure (systolic, mean, diastolic) BP, heart rate (HR), rhythm, respiratory rate (RR).
This will ensure that the addition of saline fluid does not adversely affect haemodynamics.

Timepoint [3]

This is measured continuously via the ECG and the arterial line. This will be recorded every ten seconds during the physiotherapy treatment with the actual time of saline instillation marked and the values printed from the monitor (Intellivue, Phillips) after the procedure.

Secondary outcome [4]

SpO2 - oxygen saturation
The amount of oxygen dissolved in the haemoglobin. It is measured non-invasively by a probe on the finger.

Timepoint [4]

This is measured continuously and will be recorded every 10 seconds and a hard copy printed at the completion of the measurement period.

Eligibility

Key inclusion criteria

1] Adults >18 years, mechanically ventilated
2] Expected to be ventilated for >48 hours
3] Arterial line in situ (for blood pressure measurement and to calculate P/F ratio)
4] Next of kin or patient able to provide informed consent

Minimum age

18 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1] Compassionate care only
2] Condition that contraindicates respiratory physiotherapy eg high intracranial pressure, unstable haemodynamics, undrained pneumothorax, frank haemoptysis, acute pulmonary oedema
3] Ventilation modes such as high frequency oscillation

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)

The personnel determining eligibility and gaining consent will be unaware of group allocation. The allocation sequence will be concealed from these personnel as they will be stored on a password protected computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The sequence will be generated using a randomization table created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

Burns, Trauma & Critical Care Research Centre
Dept Intensive Care Medicine.
Level 3, NHB,
Royal Brisbane & Womens Hospital,
Butterfield St
Herston Queensland 4029

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Brisbane & Womens Hospital

Address [1]

Burns, Trauma & Critical Care Research centre
Dept Intensive Care Medicine.
Level 3, NHB,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston Queensland, 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane & Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Brisbane & Women's Hospital,
Block 7, Floor 7,
Butterfield St,
Herston 4029 QLD

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/04/2012

Ethics approval number [1]

HREC/12/QRBW/60

Summary

Brief summary

Insertion of an artificial airway for respiratory failure, either endotracheal, nasotracheal or tracheostomy, inhibits normal mucociliary clearance, thus increasing the risk of secretion retention and pneumonia. Suctioning of the artifical airway is one of the most common procedures in the intensive care unit and high dependency wards: the aim is to remove respiratory tract secretions, thus maintaining airway patency, and prevent complications of secretion retention. Normal saline instillation is defined as delivery of 2 to 10 cc of normal saline solution (0.9%) into an artificial airway prior to suctioning. This technique is utilised by many health practitioners and is believed to increase sputum yield by diluting and loosening secretions, stimulating a cough and lubricating the suction catheter. However, there are conflicting views about the safety and efficacy of this procedure. To date studies have investigated saline instillation as a stand alone technique and not as part of a respiratory physiotherapy regimen.

The aim of this trial is to examine the effects of normal saline instillation on sputum clearance, haemodynamic parameters, oxygenation and respiratory mechanics during physiotherapy in patients with an artificial airway. 

Design

Prospective, single blinded, randomised, cross-over design where patients act as their own controls. Patients will be randomised using a computer generated sequence. Those allocated to group A will have saline instillation prior to suction during physiotherapy on day one, day two no saline will be used. The reverse will happen for those patients allocated to group B. Investigator collecting outcome measures will be blinded to group allocation.

Participants
Adults >18 years, expected to be mechanically ventilated for >48 hours.

Outcome measures
The primary outcome measure is sputum weight. Sputum will be collected during physiotherapy.Secondary outcome measures include airway resistance, oxygenation, blood pressure and heart rate which will be calculated at various times pre and post procedure. 

Significance
This study would add to the body of knowledge regarding the efficacy and safety of saline instillation during physiotherapy in the intensive care unit.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Kellie Stockton

Address

Burns, Trauma & Critical Care Research Centre
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Butterfield St
Herston, Queensland, 4029

Country

Australia

Phone

+61 7 36367893

Fax

+61 7 36363542

k.stockton@uq.edu.au

Contact person for scientific queries

Name

Dr Jennifer Paratz

Address

Burns, Trauma & Critical Care Research Centre
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston, Queensland, 4029

Country

Australia

Phone

+61 7 36361980

Fax

+61 7 36363542

j.paratz@uq.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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