Hypertensive PatientsNCT03316443
A Comparative Study of Glidescope Versus Macintosh Laryngoscope in Adult Hypertensive Patients
A study testing Glidescope and Macintosh in people with Hypertensive Patients, run by Mansoura University at 1 site in Egypt.
Trial summary
Hemodynamic response to laryngoscopy and tracheal intubation remain of utmost concern in anesthesia practice. Sympathetic stimulation and adverse physiologic events could be tolerated by healthy individuals, but they may be detrimental in hypertensive patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertensive Patients
- What is being tested?
- Glidescope and Macintosh
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Dec 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 20 year old.
- Patients classified by the American society of anesthesiologist as 2 or 3 with controlled hypertension.
- Patients with body mass index less than 35.
- Mallampati score 1 or 2, thyromental distance more than 4 cm and central incisor interdistance more than 3 cm will included.
Who cannot join
- Patient refusal.
- Patient with uncontrolled hypertension (patients diagnosed as uncontrolled hypertension if they have history of hypertension and systolic blood pressure after 3 measures after admission exceeding 150 mmHg despite of regular antihypertensive therapy).
- Patient with major cardiac diseases (e.g cardiomyopathy).
- Patient with cerebrovascular accidents.
- Patient with history of difficult intubation.
- Patients at risk of aspiration who require rapid sequence induction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Comparative Study of Glidescope Versus Macintosh Laryngoscope in Adult Hypertensive Patients
Hemodynamic response to laryngoscopy and tracheal intubation remain of utmost concern in anesthesia practice. Sympathetic stimulation and adverse physiologic events could be tolerated by healthy individuals, but they may be detrimental in hypertensive patients.
The magnitude of hemodynamic response of intubation is related to the degree of manipulation of the oropharyngeo-laryngeal structures. Unlike Macintosh laryngoscope,Glidescope is a device that does not require alignment of oropharyngeal axis to visualize the glottis.It needs less upward lifting force with less manipulation of pharyngeal structures during the intubation.
It was reported that Glidescope had no significant advantage over Macintosh in attenuating circulatory response to endotracheal intubation in normotensive patients.Till now no clinical trials investigate the hemodynamic effects of Glidescope in hypertensive patients.The investigators hypothesized that the Glidescope will induce less hemodynamic changes among hypertensive patients during endotracheal intubation.So the study was designed to compare effects of Glidescope versus Macintosh laryngoscope in hypertensive patients with special regard to hemodynamics and intubation conditions.
Read the detailed description
This is prospective randomized study will performed at Urology and Nephrology Centre, Mansoura University after approval from Institutional Research Board, Mansoura University.Patients were interviewed and written informed consent will be obtained from selected patients scheduled for different urological surgeries.
Eligible adult patients will be randomly allocated by a computer-generated randomization sequence into 2 equal groups:
Macintosh group: 45 patients will be intubated by Macintosh laryngoscope(Group M).
Glidescope group: 45 patients will be intubated by Glidescope(Group G).
Preoperative assessment:
All patients will be assessed preoperatively by:
- History taking (for medical and surgical history)
- Physical examination (including heart, blood pressure, electrocardiogram, chest auscultation and difficult airway assessment)
- Laboratory investigation (complete blood picture, renal and liver function tests and bleeding profile).
The day before surgery, the study protocol will explained to all patients and the patients will fast for 6 hours before the surgery. All the patients will receive their antihypertensive medications till the morning of surgery
On arrival to the operation room:
Routine monitoring including: electrocardiogram, non-invasive blood pressure and pulse oximetry will be set, Peripheral intravenous cannula will be inserted and acetated Ringer will be started at rate of 4ml/kg/h.
Anesthetic management:
The induction will be similar in both groups; Pre-oxygenation for 5 minutes will be done in all patients and then they will receive 0.02 mg/Kg midazolam, 1μg/Kg fentanyl, 2mg/kg Propofol slowly until loss of verbal contact and rocurronium 0.6 mg/kg intravenously.Till the establishment of adequate neuromuscular block, the patients' ventilation will be assisted manually using a face mask. During this period the patients' lungs will be ventilated with 100% oxygen.
After establishment of adequate neuromuscular block after 3 minutes, the trachea will be intubated using either glidescope or Macintosh laryngoscope.The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3, the laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced.For endotracheal intubation with glidescope, size 3 blade will be used in all of the cases. Glidescope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator.
External pressure to the front of the neck will be applied on request of the operator by another anesthetist.After placement of the endotracheal tube, the cuff of the tube will be inflated gradually with and the chest will be auscultated to ensure proper tracheal positioning and to exclude bronchial intubation and then the tube will be fixed.
All the intubations will be performed by a well-trained anesthetist. The intubation attempt failure will be defined when the intubation time exceed 120 seconds, esophageal intubation occurred or desaturation with arterial oxygen saturation dropped below 90%. Three attempts will only allow,then anesthesia will be carried out according to decision of the attending anesthetist with exclusion of the case from the study. Face-mask intermittent positive pressure ventilation will be carried out in-between the attempts.
The intubation condition will be assessed using first attempt success rate, number of attempts, intubation time and Cormack Lehane score. The intubation time is defined as the period from termination of face mask oxygenation till the appearance of carbon dioxide trace after positive pressure ventilation.
Cormack Lehane score is based on the laryngoscopic view as following: grade 1 full view of the glottis, grade 2 partial view of the glottis, grade 3 only the epiglottis appear and grade 4 neither the glottis nor the epiglottis appear
Monitoring:
Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.Maximal blood pressure and heart rate changes will be recorded
Postoperative follow up:
The patient will be assessed 24 hours postoperatively for the sore throat and hoarseness of voice according to the 4-point score
- Conditions
- Hypertensive Patients
- Being tested
- Glidescope, Macintosh
- Keywords
- Glidescope,Macintosh, Laryngscope, intubation,Hypertension.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlidescopeDevice
The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter).
For endotracheal intubation with glidescope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator.
Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.
MacintoshDevice
The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first. The laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced.Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.Maximal arterial blood pressure and heart rate changes will be recorded
| Study group | Role | What they receive |
|---|---|---|
| (Group G) | Active comparator | Glidescope group: 45 patients will be intubated by Glidescope (Group G). For endotracheal intubation with glidoscope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator. Receives: Device: Glidescope |
| (Group M) | Experimental | Macintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M).The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first, the laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced Receives: Device: Macintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood pressure changes
Systolic arterial blood pressure changes with the use of each device for endotracheal intubation.
Measured: During 10 minutes after endotracheal inubation.
Arterial blood pressure changes
Diastolic arterial blood pressure changes with the use of each device for endotracheal intubation.
Measured: During 10 minutes after endotracheal intubation.
Arterial blood pressure changes
Mean arterial blood pressure changes with the use of each device for endotracheal intubation.
Measured: During 10 minutes of trial of endotracheal intubation.
Heart rate changes
Heart rate changes with the use of each device for endotracheal intubation.
Measured: During 10 minutes of trial of endotracheal intubation.
Secondary outcomes (5)
Success rate of endotracheal intubation with each device.
First attempt success rate for endotracheal intubation completion.
Measured: During intraoperative trial of endotracheal intubation.
Endotracheal intubation time with each device.
Total time needed from end of mask ventilation untill endotracheal intubation completion with appearance of CO2 traces.
Measured: During intraoperative trials of endotracheal intubation.
Attempts of endotracheal intubation with each device.
Number of attempts needed for completion of endotracheal intubation.
Measured: During intraoperative trials of endotracheal intubation.
severity of sore throat with each device.
Sore throat will be graded as none, mild (less severe than with common cold), moderate (similar to common cold) and severe (more severe than with common cold).
Measured: 24 hours after endotracheal intubation
severity of hoarseness of voice with each device.
Hoarseness of voice will be graded as none, mild (noted only by the patient), moderate (obvious to the observer) and sever (like aphonia).
Measured: 24 hours after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Feb 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive PatientsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible 90 adult patients will be randomly allocated by a computer-generated randomization sequence into 2 equal groups: Macintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M). Glidescope group: 45 patients will be intubated by Glidescope (Group G).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mahmoud Othman, Mansoura University
- Investigators
- Mahmoud M Othman, MD, Principal investigator, Faculty of Medicine, Mansoura University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316443
- Sponsor's protocol ID
- MS/17.10.93
- Status last verified
- Jan 2021
- First submitted
- 12 Oct 2017
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Study of Glidescope Versus Macintosh Laryngoscope in Adult Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03316443
- Acronym / sponsor ID
- MS/17.10.93
- Conditions
- Hypertensive Patients
- Keywords
- Glidescope,Macintosh, Laryngscope, intubation,Hypertension.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 20 Oct 2017 (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.
Hemodynamic response to laryngoscopy and tracheal intubation remain of utmost concern in anesthesia practice. Sympathetic stimulation and adverse physiologic events could be tolerated by healthy individuals, but they may be detrimental in hypertensive patients.
The magnitude of hemodynamic response of intubation is related to the degree of manipulation of the oropharyngeo-laryngeal structures. Unlike Macintosh laryngoscope,Glidescope is a device that does not require alignment of oropharyngeal axis to visualize the glottis.It needs less upward lifting force with less manipulation of pharyngeal structures during the intubation.
It was reported that Glidescope had no significant advantage over Macintosh in attenuating circulatory response to endotracheal intubation in normotensive patients.Till now no clinical trials investigate the hemodynamic effects of Glidescope in hypertensive patients.The investigators hypothesized that the Glidescope will induce less hemodynamic changes among hypertensive patients during endotracheal intubation.So the study was designed to compare effects of Glidescope versus Macintosh laryngoscope in hypertensive patients with special regard to hemodynamics and intubation conditions.
Detailed description
This is prospective randomized study will performed at Urology and Nephrology Centre, Mansoura University after approval from Institutional Research Board, Mansoura University.Patients were interviewed and written informed consent will be obtained from selected patients scheduled for different urological surgeries.
Eligible adult patients will be randomly allocated by a computer-generated randomization sequence into 2 equal groups:
Macintosh group: 45 patients will be intubated by Macintosh laryngoscope(Group M).
Glidescope group: 45 patients will be intubated by Glidescope(Group G).
Preoperative assessment:
All patients will be assessed preoperatively by:
- History taking (for medical and surgical history)
- Physical examination (including heart, blood pressure, electrocardiogram, chest auscultation and difficult airway assessment)
- Laboratory investigation (complete blood picture, renal and liver function tests and bleeding profile).
The day before surgery, the study protocol will explained to all patients and the patients will fast for 6 hours before the surgery. All the patients will receive their antihypertensive medications till the morning of surgery
On arrival to the operation room:
Routine monitoring including: electrocardiogram, non-invasive blood pressure and pulse oximetry will be set, Peripheral intravenous cannula will be inserted and acetated Ringer will be started at rate of 4ml/kg/h.
Anesthetic management:
The induction will be similar in both groups; Pre-oxygenation for 5 minutes will be done in all patients and then they will receive 0.02 mg/Kg midazolam, 1μg/Kg fentanyl, 2mg/kg Propofol slowly until loss of verbal contact and rocurronium 0.6 mg/kg intravenously.Till the establishment of adequate neuromuscular block, the patients' ventilation will be assisted manually using a face mask. During this period the patients' lungs will be ventilated with 100% oxygen.
After establishment of adequate neuromuscular block after 3 minutes, the trachea will be intubated using either glidescope or Macintosh laryngoscope.The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3, the laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced.For endotracheal intubation with glidescope, size 3 blade will be used in all of the cases. Glidescope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator.
External pressure to the front of the neck will be applied on request of the operator by another anesthetist.After placement of the endotracheal tube, the cuff of the tube will be inflated gradually with and the chest will be auscultated to ensure proper tracheal positioning and to exclude bronchial intubation and then the tube will be fixed.
All the intubations will be performed by a well-trained anesthetist. The intubation attempt failure will be defined when the intubation time exceed 120 seconds, esophageal intubation occurred or desaturation with arterial oxygen saturation dropped below 90%. Three attempts will only allow,then anesthesia will be carried out according to decision of the attending anesthetist with exclusion of the case from the study. Face-mask intermittent positive pressure ventilation will be carried out in-between the attempts.
The intubation condition will be assessed using first attempt success rate, number of attempts, intubation time and Cormack Lehane score. The intubation time is defined as the period from termination of face mask oxygenation till the appearance of carbon dioxide trace after positive pressure ventilation.
Cormack Lehane score is based on the laryngoscopic view as following: grade 1 full view of the glottis, grade 2 partial view of the glottis, grade 3 only the epiglottis appear and grade 4 neither the glottis nor the epiglottis appear
Monitoring:
Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.Maximal blood pressure and heart rate changes will be recorded
Postoperative follow up:
The patient will be assessed 24 hours postoperatively for the sore throat and hoarseness of voice according to the 4-point score
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible 90 adult patients will be randomly allocated by a computer-generated randomization sequence into 2 equal groups: Macintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M). Glidescope group: 45 patients will be intubated by Glidescope (Group G).
| Arm | Type | Receives |
|---|---|---|
| (Group G) | Active comparator | Device: GlidescopeGlidescope group: 45 patients will be intubated by Glidescope (Group G). For endotracheal intubation with glidoscope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator. |
| (Group M) | Experimental | Device: MacintoshMacintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M).The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first, the laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged more than 20 year old.
- Patients classified by the American society of anesthesiologist as 2 or 3 with controlled hypertension.
- Patients with body mass index less than 35.
- Mallampati score 1 or 2, thyromental distance more than 4 cm and central incisor interdistance more than 3 cm will included.
Key exclusion criteria (6 listed)
- Patient refusal.
- Patient with uncontrolled hypertension (patients diagnosed as uncontrolled hypertension if they have history of hypertension and systolic blood pressure after 3 measures after admission exceeding 150 mmHg despite of regular antihypertensive therapy).
- Patient with major cardiac diseases (e.g cardiomyopathy).
- Patient with cerebrovascular accidents.
- Patient with history of difficult intubation.
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 |
|---|---|---|
| GlidescopeThe patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). For endotracheal intubation with glidescope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator. Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation. | Device | (Group G) |
| MacintoshThe patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first. The laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced.Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.Maximal arterial blood pressure and heart rate changes will be recorded | Device | (Group M) |
Primary outcome
Arterial blood pressure changes
Time frame: During 10 minutes after endotracheal inubation.
Systolic arterial blood pressure changes with the use of each device for endotracheal intubation.
Arterial blood pressure changes
Time frame: During 10 minutes after endotracheal intubation.
Diastolic arterial blood pressure changes with the use of each device for endotracheal intubation.
Arterial blood pressure changes
Time frame: During 10 minutes of trial of endotracheal intubation.
Mean arterial blood pressure changes with the use of each device for endotracheal intubation.
Heart rate changes
Time frame: During 10 minutes of trial of endotracheal intubation.
Heart rate changes with the use of each device for endotracheal intubation.
5 secondary outcomes
Success rate of endotracheal intubation with each device.
Time frame: During intraoperative trial of endotracheal intubation.
Endotracheal intubation time with each device.
Time frame: During intraoperative trials of endotracheal intubation.
Attempts of endotracheal intubation with each device.
Time frame: During intraoperative trials of endotracheal intubation.
severity of sore throat with each device.
Time frame: 24 hours after endotracheal intubation
severity of hoarseness of voice with each device.
Time frame: 24 hours after endotracheal intubation
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 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertensive Patients
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
RecruitingObservational study
Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank
Malignant Hypertension
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.
Mahmoud M Othman, MD principal investigator
Faculty of Medicine, Mansoura University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glidescope and Macintosh in people with Hypertensive Patients, run by Mansoura University at 1 site in Egypt.
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 4 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 12 Jan 2021. 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 Egypt. 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?
Arterial blood pressure changes (time frame: During 10 minutes after endotracheal inubation.). The study lists 4 primary outcomes in all. 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 12 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.