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NCT Number: NCT06207513

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

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.

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dkahliya, 33156, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suction Circuit Flushing with Chlorhexidine

Procedure

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

Primary outcomes

  1. Feasibility of intervention

    Time frame: through study completion, an average of 1 year

    The feasibility and acceptability of the proposed intervention among healthcare professionals in study settings and determine methods for the design of a conclusive randomized controlled trial.

Secondary outcomes

  1. Patients outcome

    Time frame: through study completion, an average of 1 year

    Will measure the impact of the proposed intervention on mechanically patients outcomes including Ventilator associated pneumonia incidence (using the modified clinical pulmonary infection score) and length of ICU stay

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • University of Plymouth

Registry information

Official study title

Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients: the SPECIAL-ICU Trial

Acronym: SPECIAL-ICU

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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