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Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients (SPECIAL-ICU)

M

Mansoura University

Status

Completed

Conditions

Ventilator Associated Pneumonia

Treatments

Procedure: Suction Circuit Flushing with Chlorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06207513
4112023

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Intervention I group
Experimental group
Description:
Patient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using a single-used open endotracheal suction catheter that is used only for one-time suctioning attempt and discarded after each endotracheal suction cycle. A new catheter will be used for each endotracheal suctioning procedure.
Treatment:
Procedure: Suction Circuit Flushing with Chlorhexidine
Intervention II group
Experimental group
Description:
Patient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit will be performed with 40 ml of chlorhexidine gluconate 0.2% after every endotracheal suction procedure
Treatment:
Procedure: Suction Circuit Flushing with Chlorhexidine
Control group
Other group
Description:
Patients intubated with an endotracheal tube and on a mechanical ventilator will receive standard care. This is the endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit is standardised performed using normal saline after every endotracheal suction procedure.
Treatment:
Procedure: Suction Circuit Flushing with Chlorhexidine

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Mohamed Eid

Data sourced from clinicaltrials.gov

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