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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] 280331 0
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 286293 0
Condition category
Condition code
Infection 286530 286530 0 0
Other infectious diseases
Injuries and Accidents 286531 286531 0 0
Other injuries and accidents
Injuries and Accidents 286532 286532 0 0
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] 284689 0
Treatment: Other
Comparator / control treatment
No instillation of fluid prior to physiotherapy treatment
Control group
Active

Outcomes
Primary outcome [1] 286963 0
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] 286963 0
Immediately at the end of intervention
Secondary outcome [1] 297059 0
Airway resistance (Raw) cm H2O/L/second
This measure will be derived from the mechanical ventilator.
Timepoint [1] 297059 0
Before and immediately after the intervention
Secondary outcome [2] 297129 0
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] 297129 0
An arterial blood gas will be taken immediately pre, post and 60 minutes post intervention.
Secondary outcome [3] 297130 0
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] 297130 0
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] 297131 0
SpO2 - oxygen saturation
The amount of oxygen dissolved in the haemoglobin. It is measured non-invasively by a probe on the finger.
Timepoint [4] 297131 0
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?
No
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
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285109 0
Self funded/Unfunded
Name [1] 285109 0
Country [1] 285109 0
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] 283964 0
Hospital
Name [1] 283964 0
Royal Brisbane & Womens Hospital
Address [1] 283964 0
Burns, Trauma & Critical Care Research centre
Dept Intensive Care Medicine.
Level 3, NHB,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston Queensland, 4029
Country [1] 283964 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287118 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 287118 0
Royal Brisbane & Women's Hospital,
Block 7, Floor 7,
Butterfield St,
Herston 4029 QLD
Ethics committee country [1] 287118 0
Australia
Date submitted for ethics approval [1] 287118 0
Approval date [1] 287118 0
13/04/2012
Ethics approval number [1] 287118 0
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 34071 0
Address 34071 0
Country 34071 0
Phone 34071 0
Fax 34071 0
Email 34071 0
Contact person for public queries
Name 17318 0
Kellie Stockton
Address 17318 0
Burns, Trauma & Critical Care Research Centre
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Butterfield St
Herston, Queensland, 4029
Country 17318 0
Australia
Phone 17318 0
+61 7 36367893
Fax 17318 0
+61 7 36363542
Email 17318 0
[email protected]
Contact person for scientific queries
Name 8246 0
Dr Jennifer Paratz
Address 8246 0
Burns, Trauma & Critical Care Research Centre
Dept Intensive Care Medicine,
Level 3, NHB
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston, Queensland, 4029
Country 8246 0
Australia
Phone 8246 0
+61 7 36361980
Fax 8246 0
+61 7 36363542
Email 8246 0
[email protected]

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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