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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000432819
Acronym
Saline Instillation during Physiotherapy (SIP)
Enrollment
35
Registered
2012-04-17
Start date
2012-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026