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

Ventilator Associated Pneumonia Clinical Trial

— SPECIAL-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207513
• Other study ID #: 4112023
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Mansoura University
• Contact: Mohamed Eid
• Phone: 07399146606
• Email: Mohamed.eid[@]plymouth.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• Suction Circuit Flushing with Chlorhexidine
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

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dkahliya

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	University of Plymouth

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intervention	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.	through study completion, an average of 1 year
Secondary	Patients outcome	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	through study completion, an average of 1 year