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

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

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Procedure: Suction Circuit Flushing with Chlorhexidine

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Eid; Phone Number: 07399146606; Email: Mohamed.eid@plymouth.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention I group; 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.	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
Experimental: Intervention II group; 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	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
Other: Control group; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ventilator Associated Pneumonia	at day three and day six of mechanical ventilation

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: University of Plymouth

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 4112023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No