None listed
Conditions
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.
Interventions
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 wi
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.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
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
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
Outcome results
None listed