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NCT05620108 Clinical Trial

Intubating Conditions of Neuromuscular Blockade

Endotracheal Intubation Clinical Trial

Official title:
Intubating Conditions at Various Levels of Neuromuscular Blockade

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05620108
Other study ID # 22-009153
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 28, 2022
Est. completion date December 2024

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to learn about the difference in the endotracheal intubation condition (ease of using a device to view vocal cords, position of vocal cords, and patient's reaction to endotracheal tube insertion) and determining the appropriate time to perform the intubation.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 170
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients willing to participate and provide an informed consent. - Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively. Exclusion Criteria: - Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury. - Patients with systemic neuromuscular diseases such as myasthenia gravis. - Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease. - Patients having surgery that would involve prepping the arm into the sterile field. - Patients receiving a rapid sequence induction.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endotracheal Intubation at TOFC=1
Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade
• Endotracheal Intubation 2 minutes after rocuronium administration
Intubation using a video laryngoscopy will be performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)

Locations
Country Name City State
United States Mayo Clinic Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of the intubating conditions Evaluated by the healthcare providers using a scale that includes 4 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions. Approximately 15 minutes after intubation
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