Aged PatientsNCT02816775
Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients
A study testing Macintosh Laryngoscope and McGRATH Videolaryngoscope in people with Aged Patients, run by Inonu University.
Trial summary
The intubation response to airway manipulation during direct laryngoscopy can cause hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense physiological response is proven to be associated with adverse outcomes especially in elderly patients. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Aged Patients
- What is being tested?
- Macintosh Laryngoscope and McGRATH Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Nov 2016
- Phase
- Interventional
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- scheduled for elective surgery under general anesthesia requiring tracheal intubation
Who cannot join
- hypertension,
- cardiopulmonary disease,
- diabetes mellitus,
- a predicted problematic airway,
- morbid obesity,
- the use of medications known to affect blood pressure and heart rate as β-adrenergic blockers
About this study
Official title: Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients: A Randomized, Controlled Trial
The intubation response to airway manipulation during direct laryngoscopy can cause hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense physiological response is proven to be associated with adverse outcomes especially in elderly patients. Increased QT dispersion is associated with increased risk of ventricular arrhythmias, which may increase the risk of sudden death caused by life-threatening arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic response than the conventional method of direct laryngoscopy. The objective of this study was to compare the hemodynamic response and QT during following tracheal intubation, using videolaryngoscope or direct laryngoscope to intubation. The postoperative airway morbidities is the investigators secondary outcome.
Read the detailed description
Ninety patients, aged over 65 years, scheduled for elective surgery under general anesthesia requiring tracheal induction will be included in this study.
All patients will divided into two groups by a sealed envelope technique, Group Laryngoscope; n = 45 and Group Videolaryngoscope; n = 45 to receive tracheal intubation using either a Macintosh laryngoscope (Group L) or a McGRATH videolaryngoscope (Group V).
Hemodynamic data will evaluated by an anesthesiologist who was blinded to the study group affiliations. Evaluation of ECG will performed by a cardiologist.
None of the patients will premedicated with any drug. Standard monitors, including ECG (lead II), noninvasive systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and peripheral oxygen saturation (SpO2) measurements will be and mallampati classification, thyromental distance and mouth opening will be evaluated. After preoxygenation, anesthesia will induced with propofol 1.5 mg/kg. After loss of consciousness, rocuronium 0.5 mg/kg will injected intravenously (IV). Two minutes after rocuronium administration, fentanyl 2.0 μg/kg was given to each patient, and intubation will attempted with the direct laryngoscopy or McGrath Videolaryngoscopy. Anesthesia will maintained with sevoflurane in a mixture of 50% oxygen in 50% nitrous oxide.
The following parameters will measured by a blind observer: number of intubation trials, intubation time (from insertion of the intubation device into the mouth to capnographic confirmation), airway trauma (detection of blood drops in the mouth, lip or the tube after removal). SBP, DBP, MAP heart rate and electrocardiography (ECG) will recorded at the following time points: before induction of anesthesia (pre-induction, T0), before tracheal intubation (post-induction, T1), 1,3,5 min post-intubation (T2, T3, T4, respectively).
A 12-lead surface ECG was obtained from each subject while placed in the supine position. The 12-lead ECG was recorded at a standardized article speed of 50 mm/sec and 2.0 millivolt/cm. Measurement of QT interval duration will carried out manually using a caliper.
Pharyngolaryngeal injury in all patients will assessed by asking about sore throat and hoarseness 24 h after the surgery using an 4-point scale: none, mild, moderate and severe.
- Conditions
- Aged Patients
- Being tested
- Macintosh Laryngoscope, McGRATH Videolaryngoscope
- Keywords
- hemodynamics, QT interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh LaryngoscopeDevice
After induction of anesthesia, tracheal intubation will made by Macintosh Laryngoscope
McGRATH VideolaryngoscopeDevice
After induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group Laryngoscope | Active comparator | Group Laryngoscope; intubation will be made by Macintosh laryngoscope Receives: Device: Macintosh Laryngoscope |
| Group Videolaryngoscope | Active comparator | Group Videolaryngoscope; intubation will be made by McGRATH Videolaryngoscope Receives: Device: McGRATH Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean blood pressure
The patient's blood pressure should be measured and recorded at 5-minute intervals during the first 30 minutes of the operation.
Measured: Change from baseline mean blood pressure at 30 minutes
Secondary outcomes (3)
QT interval
The QT interval in the ECG recordings in the first 30 minutes will be evaluated.
Measured: Change from baseline QT interval at 30 minutes
heart rate
The patient's heart rate should be measured and recorded at 5-minute intervals during the first 30 minutes of the operation.
Measured: Change from baseline heart rate at 30 minutes
Number of participants with treatment-related adverse events as assessed by 4- point scale
Sore throat and hoarseness is graded as: none, mild, moderate, severe
Measured: From extubation until postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aged PatientsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Özgül, Inonu University
- Investigators
- Türkan Toğal, Prof., Study director, Inonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816775
- Sponsor's protocol ID
- Ulku2
- Status last verified
- Aug 2022
- First submitted
- 20 Jun 2016
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tempe DK, Chaudhary K, Diwakar A, Datt V, Virmani S, Tomar AS, Mohandas A, Mohire VB. Comparison of hemodynamic responses to laryngoscopy and intubation with Truview PCD, McGrath(R) and Macintosh laryngoscope in patients undergoing coronary artery bypass grafting: A randomized prospective study. Ann Card Anaesth. 2016 Jan-Mar;19(1):68-75. doi: 10.4103/0971-9784.173023.
PubMed 26750677
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02816775
- Acronym / sponsor ID
- Ulku2
- Conditions
- Aged Patients
- Keywords
- hemodynamics, QT interval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
The intubation response to airway manipulation during direct laryngoscopy can cause hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense physiological response is proven to be associated with adverse outcomes especially in elderly patients. Increased QT dispersion is associated with increased risk of ventricular arrhythmias, which may increase the risk of sudden death caused by life-threatening arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic response than the conventional method of direct laryngoscopy. The objective of this study was to compare the hemodynamic response and QT during following tracheal intubation, using videolaryngoscope or direct laryngoscope to intubation. The postoperative airway morbidities is the investigators secondary outcome.
Detailed description
Ninety patients, aged over 65 years, scheduled for elective surgery under general anesthesia requiring tracheal induction will be included in this study.
All patients will divided into two groups by a sealed envelope technique, Group Laryngoscope; n = 45 and Group Videolaryngoscope; n = 45 to receive tracheal intubation using either a Macintosh laryngoscope (Group L) or a McGRATH videolaryngoscope (Group V).
Hemodynamic data will evaluated by an anesthesiologist who was blinded to the study group affiliations. Evaluation of ECG will performed by a cardiologist.
None of the patients will premedicated with any drug. Standard monitors, including ECG (lead II), noninvasive systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and peripheral oxygen saturation (SpO2) measurements will be and mallampati classification, thyromental distance and mouth opening will be evaluated. After preoxygenation, anesthesia will induced with propofol 1.5 mg/kg. After loss of consciousness, rocuronium 0.5 mg/kg will injected intravenously (IV). Two minutes after rocuronium administration, fentanyl 2.0 μg/kg was given to each patient, and intubation will attempted with the direct laryngoscopy or McGrath Videolaryngoscopy. Anesthesia will maintained with sevoflurane in a mixture of 50% oxygen in 50% nitrous oxide.
The following parameters will measured by a blind observer: number of intubation trials, intubation time (from insertion of the intubation device into the mouth to capnographic confirmation), airway trauma (detection of blood drops in the mouth, lip or the tube after removal). SBP, DBP, MAP heart rate and electrocardiography (ECG) will recorded at the following time points: before induction of anesthesia (pre-induction, T0), before tracheal intubation (post-induction, T1), 1,3,5 min post-intubation (T2, T3, T4, respectively).
A 12-lead surface ECG was obtained from each subject while placed in the supine position. The 12-lead ECG was recorded at a standardized article speed of 50 mm/sec and 2.0 millivolt/cm. Measurement of QT interval duration will carried out manually using a caliper.
Pharyngolaryngeal injury in all patients will assessed by asking about sore throat and hoarseness 24 h after the surgery using an 4-point scale: none, mild, moderate and severe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Laryngoscope | Active comparator | Device: Macintosh LaryngoscopeGroup Laryngoscope; intubation will be made by Macintosh laryngoscope |
| Group Videolaryngoscope | Active comparator | Device: McGRATH VideolaryngoscopeGroup Videolaryngoscope; intubation will be made by McGRATH Videolaryngoscope |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- scheduled for elective surgery under general anesthesia requiring tracheal intubation
Key exclusion criteria (6 listed)
- hypertension,
- cardiopulmonary disease,
- diabetes mellitus,
- a predicted problematic airway,
- morbid obesity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macintosh LaryngoscopeAfter induction of anesthesia, tracheal intubation will made by Macintosh Laryngoscope | Device | Group Laryngoscope |
| McGRATH VideolaryngoscopeAfter induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope | Device | Group Videolaryngoscope |
Primary outcome
mean blood pressure
Time frame: Change from baseline mean blood pressure at 30 minutes
The patient's blood pressure should be measured and recorded at 5-minute intervals during the first 30 minutes of the operation.
3 secondary outcomes
QT interval
Time frame: Change from baseline QT interval at 30 minutes
heart rate
Time frame: Change from baseline heart rate at 30 minutes
Number of participants with treatment-related adverse events as assessed by 4- point scale
Time frame: From extubation until postoperative 24 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 30 Aug 2022.
- Results publication: PubMed 26750677Tempe DK, Chaudhary K, Diwakar A, Datt V, Virmani S, Tomar AS, Mohandas A, Mohire VB. Comparison of hemodynamic responses to laryngoscopy and intubation with Truview PCD, McGrath(R) and Macintosh laryngoscope in patients undergoing coronary artery bypass grafting: A randomized prospective study. Ann Card Anaesth. 2016 Jan-Mar;19(1):68-75. doi: 10.4103/0971-9784.173023.
- Individual participant dataSharing planned: No
Related trials for Aged Patients
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Türkan Toğal, Prof. study director
Inonu University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh Laryngoscope and McGRATH Videolaryngoscope in people with Aged Patients, run by Inonu University.
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 1 inclusion and 6 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
mean blood pressure (time frame: Change from baseline mean blood pressure at 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816775, which also lists 1 linked publication.
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 30 Aug 2022.