Clinical trial NCT06207513: Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients
Official title: Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients: the SPECIAL-ICU Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: University of Plymouth
First posted: 2024-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In low and middle-income countries, open endotracheal suction catheters are used multiple times to perform suctioning due to limited resources \[1,2\]. Currently, there is limited evidence for using a new suction catheter for each suction pass, acknowledged in a review article of endotracheal suction procedures in paediatric populations \[3\]. Additionally, the latest artificial airway suctioning practice guidelines published by the American Association for Respiratory Care in 2022 did not mention any recommendations regarding suction catheter changing frequency \[4\]. The guidelines adopted a study conducted in 2001 which showed that reusing an open tracheal suctioning catheter is safe and cost effective \[5\]. Therefore, the current evidence of reusing suctioning catheters remains unclear, which rationalize the reason why some resource limited Intensive Care Units (ICUs) use the catheter multiple times during a 12-hour shift, and possibly explain the high ventilator associated pneumonia (VAP) incidence in these ICUs \[1,2\].

Therefore, this feasibility study will propose to explore whether single-used suction catheters or multiple used open endotracheal tracheal suctioning catheters flushed with chlorhexidine are associated with reduced VAP incidence and its impact on mechanically ventilated patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients (aged ≥ 18 years old) who are admitted to the ICU, intubated with an endotracheal tube and receiving mechanical ventilation support directly after intubation with an expected mechanical ventilation support of at least 48 hours.
* All adults' patients meeting the above criteria whose relatives agree for them to be part of the study via deferred consent process

Exclusion Criteria:

* Patients who have received already standard care at ICU admission (the use of an endotracheal suction catheter multiple times during endotracheal suction procedures)
* Patients with contraindications to endotracheal suctioning procedure such as increased intracranial pressure, severe haemoptysis, and cerebrospinal fluid leaks.
* Patients who are previously intubated during the current hospital admission.
* Patients expected to receive mechanical ventilation less than 72 hours.
* Patients diagnosed with pneumonia at ICU admission.
* Patients having a Modified Clinical Pulmonary Infection Score (MCPIS) of 5 or greater.
* Patients with atelectasis, ARDS, and pulmonary oedema.
* Patients known to be allergic to chlorhexidine.
* Patients whose family (next-of-kin) have not provided deferred consent within 48 hours after ICU admission will be excluded and standard care will be provided.

Primary outcomes:
measure: Feasibility of intervention
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Patients outcome
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dkahliya
Study officials:
References: