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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT05160207

Collaborator

(none)

Enrollment

Location

3.9

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Tracheal Intubation Airway Management Heart Rate

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 4, 2021

Anticipated Primary Completion Date :

Feb 4, 2022

Anticipated Study Completion Date :

Mar 4, 2022

Outcome Measures

Primary Outcome Measures

Intraoperative decrease of the heart rate [1 hour]
Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)

Secondary Outcome Measures

Intraoperative asystolia [1 hour]
Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)
Application of atropine sulfate [1 hour]
Intraoperative application of atropine sulfate by the responsible anesthetist
Application of positive inotropic drugs [1 hour]
Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist
Cardiac arrhythmias [1 hour]
Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)
Hypotension [1 hour]
Intraoperative blood pressure measurement
Application of catecholamines or vasoactive drugs [1 hour]
Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist
Adverse cardiocirulatory events [1 hour]
Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist
PACU stay [8 hours]
Length of stay in the postanesthesia care unit (PACU)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Study Chair: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf
Study Chair: Tanja Peters, Universitätsklinikum Hamburg-Eppendorf
Study Chair: Christian Zöllner, MD, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT05160207

Other Study ID Numbers:

2021-10378-BO-ff

First Posted:

Dec 16, 2021

Last Update Posted:

Dec 16, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

Laryngoscopy

Bradycardia

Microlaryngoscopy

Additional relevant MeSH terms:

Bradycardia

Study Results

No Results Posted as of Dec 16, 2021