Tracheal IntubationNCT05160207
Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia
An observational study of Tracheal Intubation and Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation, Airway Management, Heart Rate
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2021to 13 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients requiring general anesthesia with tracheal intubation for elective MLS
- Age ≥ 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial
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.
Read the 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.
- Conditions
- Tracheal Intubation, Airway Management, Heart Rate
- Keywords
- Laryngoscopy, Bradycardia, Microlaryngoscopy
- Medical subject headings
- Bradycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative decrease of the heart rate
Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)
Measured: 1 hour
Secondary outcomes (8)
Intraoperative asystolia
Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)
Measured: 1 hour
Application of atropine sulfate
Intraoperative application of atropine sulfate by the responsible anesthetist (yes/no)
Measured: 1 hour
Application of positive inotropic drugs
Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no)
Measured: 1 hour
Cardiac arrhythmias
Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)
Measured: 1 hour
Hypotension
Intraoperative blood pressure measurement
Measured: 1 hour
Application of catecholamines or vasoactive drugs
Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no)
Measured: 1 hour
Adverse cardiocirulatory events
Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist
Measured: 1 hour
PACU stay
Length of stay in the postanesthesia care unit (PACU)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start4 Nov 2021
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, MD, Study chair, Universitätsklinikum Hamburg-EppendorfTanja Peters, Study chair, Universitätsklinikum Hamburg-EppendorfChristian Zöllner, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160207
- Sponsor's protocol ID
- 2021-10378-BO-ff
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05160207
- Acronym / sponsor ID
- 2021-10378-BO-ff
- Conditions
- Tracheal Intubation, Airway Management, Heart Rate
- Keywords
- Laryngoscopy, Bradycardia, Microlaryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients requiring general anesthesia with tracheal intubation for elective MLS
- Age ≥ 18
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative decrease of the heart rate
Time frame: 1 hour
Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)
8 secondary outcomes
Intraoperative asystolia
Time frame: 1 hour
Application of atropine sulfate
Time frame: 1 hour
Application of positive inotropic drugs
Time frame: 1 hour
Cardiac arrhythmias
Time frame: 1 hour
Hypotension
Time frame: 1 hour
Application of catecholamines or vasoactive drugs
Time frame: 1 hour
Adverse cardiocirulatory events
Time frame: 1 hour
PACU stay
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Petzoldt, MD study chair
Universitätsklinikum Hamburg-Eppendorf
Tanja Peters study chair
Universitätsklinikum Hamburg-Eppendorf
Christian Zöllner, MD study chair
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation and Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative decrease of the heart rate (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.