Clinical Evaluation of the Revised iLTS-D2

• Sponsor: Johannes Gutenberg University Mainz (Other)
• Overall Status: Completed
• CT.gov ID: NCT03942809
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Device: Effectiveness	N/A

Detailed Description

The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Revised iLTS-D2 in Effectivity and Practicability
• Actual Study Start Date: Aug 13, 2019
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Apr 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Effectiveness Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation	Device: Effectiveness; Effectiveness and Practicability in anesthetized patient under controlled conditions

Outcome Measures

Primary Outcome Measures

1. Insertion time LT [in 30 seconds]

   Insertion of the laryngeal tube

Secondary Outcome Measures

1. Insertion time ET [in 60 seconds]

   Insertion of the endotracheal tube

2. Rate of successful Intubation attempts [through study completion, an average of 120 seconds]

   successful insertion and tracheal intubation

3. hemodynamics MAP [through study completion, an average of 360 seconds]

   changes in MAP (mmHg) during cuff insufflation of laryngeal tube

4. hemodynamics Freq [through study completion, an average of 360 seconds]

   changes in heart frequency (bpm)

5. hemodynamics rO2 [through study completion, an average of 360 seconds]

   changes in cerebral oxygenation (percent)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• elective surgery patients under general Anesthesia

Exclusion Criteria:

• Age <18 years

• Existing pregnancy

• Lack of consent

• inability to consent

• emergency patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate	Germany	D55131

Sponsors and Collaborators

• Johannes Gutenberg University Mainz

Investigators

• Principal Investigator: Marc Kriege, MD, University Medical Center Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Kriege, MD, Principal investigator, Johannes Gutenberg University Mainz
• ClinicalTrials.gov Identifier: NCT03942809
• Other Study ID Numbers: JohannesGU-iLT
• First Posted: May 8, 2019
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marc Kriege, MD, Principal investigator, Johannes Gutenberg University Mainz: Airway Morbidity

Study Results

No Results Posted as of Apr 28, 2020