Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia

Airway Management Clinical Trial

Official title:

Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160207
• Other study ID #: 2021-10378-BO-ff
• Status: Completed
• Start date: November 4, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia.

Description:

Small studies and case series reported precipitous bradycardia or even asystole due to reflex vagal activity during tracheal intubation and/or laryngoscopy attributable to a so called laryngocardiac reflex (reflex bradycardia); however, larger systematic trials are still lacking. For the purpose of MLS, ENT surgeons frequently apply suspension laryngoscopy (Kleinsasser laryngoscope) in order to visualize the glottis and to enable surgery. Severe bradycardia has been reported during MLS that has been suspected to be induced by reflex vagal activity possibly promoted by the superior laryngeal nerve.

It is still unknown, which patients are at risk for relevant intraoperative bradycardia and moreover, which patients might benefit from preemptive measures such as prophylactic application of positive chronotropic drugs like atropine sulfate, epinephrine or glycopyrrolate. Predictive factors for MLS-induced intraoperative bradycardia have not systematically been investigated yet.

In particularly, it is unknown, if patients that present with a preoperative tracheal intubation-related decrease in heart rate have a predisposition for intraoperative reflex bradycardia during MLS.

This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia. Moreover, if we find a positive association, we further aim to determine the predictive value of intubation-relatd bradycardia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring general anesthesia with tracheal intubation for elective MLS

• Age = 18

Exclusion Criteria:

• Pregnant or breastfeeding women

• Confirmed indications for awake fiberoptic intubation

• Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)

• Patients at risk for pulmonary aspiration who qualify for rapid sequence induction

• Cardiac pacemaker

• Atrial fibrillation

• Denial of consent

Related Conditions & MeSH terms

• Airway Management
• Bradycardia
• Heart Rate
• Tracheal Intubation

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative decrease of the heart rate	Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)	1 hour
Secondary	Intraoperative asystolia	Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)	1 hour
Secondary	Application of atropine sulfate	Intraoperative application of atropine sulfate by the responsible anesthetist (yes/no)	1 hour
Secondary	Application of positive inotropic drugs	Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no)	1 hour
Secondary	Cardiac arrhythmias	Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)	1 hour
Secondary	Hypotension	Intraoperative blood pressure measurement	1 hour
Secondary	Application of catecholamines or vasoactive drugs	Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no)	1 hour
Secondary	Adverse cardiocirulatory events	Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist	1 hour
Secondary	PACU stay	Length of stay in the postanesthesia care unit (PACU)	8 hours