Application of lidocaine gel via subglottic secretion drainage during spontaneous awakening trials - a randomized double-blind cross-over study (LIDSAT)
Not Applicable
Recruiting
- Conditions
- J96.9Respiratory failure, unspecified
- Registration Number
- DRKS00031945
- Lead Sponsor
- niversität des Saarlandes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 16
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
• 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method forced expiratory efforts (FEE) by measuring the esophageal pressure (Pes):<br>• mean Pes AUC in the observation interval (main objective)
- Secondary Outcome Measures
Name Time Method • post hoc video analysis with blinded evaluators<br>• 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)<br>• differences in the Behavior Pain Scale<br><br>