NCT05160207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

November 5, 2021

Last Update Submit

July 17, 2023

Conditions

Tracheal IntubationAirway ManagementHeart Rate

Keywords

LaryngoscopyBradycardiaMicrolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Intraoperative decrease of the heart rate

    Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)

    1 hour

Secondary Outcomes (8)

  • Intraoperative asystolia

    1 hour

  • Application of atropine sulfate

    1 hour

  • Application of positive inotropic drugs

    1 hour

  • Cardiac arrhythmias

    1 hour

  • Hypotension

    1 hour

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients requiring general anesthesia with tracheal intubation for elective MLS in a tertiary care hospital who consent to participate within the study period.

You may qualify if:

  • Patients requiring general anesthesia with tracheal intubation for elective MLS
  • Age ≥ 18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Petzoldt, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

  • Tanja Peters

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

  • Christian Zöllner, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

December 16, 2021

Study Start

November 4, 2021

Primary Completion

June 13, 2022

Study Completion

June 13, 2022

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

DE(1)