NIPH Clinical Trials Search

Local analgesia using the subglottic secretion drainage port in intubated patients: a single-centre cluster randomised controlled trial.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	N/A
Date of first enrollment	01/10/2025
Target sample size	108
Countries of recruitment
Study type	Interventional
Intervention(s)	Group A: 2 ml of 2% lidocaine administered over the cuff every 6 hours for 24 hours (160 mg/24 hours) Group B: 4 ml of 4% lidocaine administered over the cuff every 6 hours for 24 hours (640 mg/24 hours) Group C: Control group Groups A and B receive lidocaine solution through the suction port on the cuff of the tracheal tube (SSD port) . The 24-hour administration refers to interventions at the start, 6, 12, and 18 hours. Both groups will receive standard analgesia with protocolized continuous IV fentanyl.

Outcome(s)

Primary Outcome

Absolute value of the CPOT score, 30 minutes after the start of the intervention.

Secondary Outcome

CPOT scores at 2, 4 and 6 hours after the start of the intervention Dose of drugs used for analgesia and sedation at 24 hours after the start of the intervention Onset of delirium up to 72 hours after the start of the intervention Ventilator-associated pneumonia (VAP) up to 7 days after the end of the intervention Ventilator free days at 28 days from the start of the intervention Lidocaine concentration in blood 15-30 minutes after the last intervention (at 18 hours). Percentage of lidocaine intoxication during the intervention.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 85age old
Gender	Both
Include criteria	Intubated patients in ICU, CCU, EICU Patients Patients aged between 18 and 85 years Patients with CPOT 2 or more Patients for whom consent has been obtained.
Exclude criteria	Patients with GCS 8 or less Patients who are expected to be extubated within 24 hours. Patients who have been previously enrolled in this study Patients with a known allergy to lidocaine Patients who need to be arrested, detained, detained, or confined by investigative or legal authorities Patients participating in clinical research involving other therapeutic interventions within the last three months Patients whose participation in the study is deemed inappropriate by the clinician