Application of lidocaine gel via subglottic secretion drainage during spontaneous awakening trials - a randomized double-blind cross-over study (LIDSAT)

Application of lidocaine gel via subglottic secretion drainage during spontaneous awakening trials - a randomized double-blind cross-over study (LIDSAT) - LIDSAT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031945

Enrollment

Registered

2023-07-10

Start date

2023-08-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J96.9

Interventions

Group 1: Application of 5 ml lidocaine gel 2% via subglottic secretion drainage prior to the start and repeat after 20 minutes Group 2: Placebo control group: Application of 5ml sodium chloride 0.9%

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • spontaneous awakening trial indicated • consent available (health care representative/supervisor) • endotracheal tube with subglottic secretion drainage present • sedation: isoflurane and remifentanil • esophageal pressure probe available

Exclusion criteria

Exclusion criteria: • immediate extubation planned • malignant hyperthermia • increased intracranial pressure • acute CNS disease in the last 14 days • extreme hemodynamic instabilityt • ECMO • patients who are permanently incapable of giving consent • lidocaine allergy • isolation in case of Covid/open tuberculosis infection • no placement of the esophageal pressure probe possible (e.g. chest stomach)

Design outcomes

Primary

Measure	Time frame
forced expiratory efforts (FEE) by measuring the esophageal pressure (Pes): • mean Pes AUC in the observation interval (main objective)	—

Secondary

Measure	Time frame
• post hoc video analysis with blinded evaluators • Time to termination the spontaneous awakening trial according to the discontinuation criteria (systolic blood pressure > 180 mmHg over 5min, tachycardia > 140/min over 5min, respiration rate > 35/min over 5min, oxygen saturation < 86%, new-onset arrhythmia at the discretion of the physician, Imminent risk to patients at the discretion of the physician) • differences in the Behavior Pain Scale	—

Measure

Time frame

• post hoc video analysis with blinded evaluators • Time to termination the spontaneous awakening trial according to the discontinuation criteria (systolic blood pressure > 180 mmHg over 5min, tachycardia > 140/min over 5min, respiration rate > 35/min over 5min, oxygen saturation < 86%, new-onset arrhythmia at the discretion of the physician, Imminent risk to patients at the discretion of the physician) • differences in the Behavior Pain Scale

—

Countries

Germany

Contacts

Public ContactAndreas Meiser

Universitätsklinikum des Saarlandes

andreas.meiser@uks.eu06841 16 22485

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026