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

NCT ID: NCT06207513

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-12-31

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Suction Circuit Flushing with Chlorhexidine

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Suction Circuit Flushing with Chlorhexidine

Intervention Type: 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

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.

Group Type: OTHER

Suction Circuit Flushing with Chlorhexidine

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Plymouth

OTHER

Sponsor Role: collaborator

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mansoura University

Al Mansurah, Dkahliya, Egypt

Countries

Egypt

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

4112023

Identifier Type: -

Identifier Source: org_study_id