Hypertension, MalignantNCT04582227
Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery
An observational study of Hypertension, Malignant and Airway Management, run by Cairo University at 1 site in Egypt.
Trial summary
the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Malignant, Airway Management
- What is being tested?
- Ambu aura-i LMA
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 22 Jun 2023
- How long will I take part?
- 5 Days
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged from 18 to 60 years presented with brain lesions undergoing craniotomies under general anaesthesia in supine position.
Who may be able to join
- Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position.
- Aged 18 to 60 years.
- ASA 1 or 2.
- GCS ≥ 13.
Who cannot join
- Patients who are known hypertensive, history of cardiac diseases or chest diseases
- Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery).
- Risk of difficult intubation
- Extensive intracranial tumours that may affect recovery of patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Ambu Aura-i Laryngeal Mask Airway Versus Endotracheal Tube on Emergence Hypertension in Supratentorial Cranial Surgery: A Randomized Controlled Study
the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.
Read the detailed description
In this study the investigators want to assess the safety of using SGA devices in cranial surgery and comparing the effect of these devices with ETT regarding hemodynamics stability throughout the procedure and intracranial tension.
- Conditions
- Hypertension, Malignant, Airway Management
- Being tested
- Ambu aura-i LMA
- Keywords
- Hypertension, airway, Laryngeal Mask Airway
- Medical subject headings
- Hypertension, Malignant, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu aura-i LMADevice
The ETT or the LMA will be inserted with the patient's head position is aided either by pins or head rest, and either the head will be in neutral position or tilted as long as the airway device is successfully placed.
| Study group | Role | What they receive |
|---|---|---|
| The ETT group | Oral endotracheal intubation via direct laryngoscopy will be performed. The ETT cuff will be inflated to 25 cmH2O using a manometer. | |
| The LMA group | The Ambu aura-i LMA size will be chosen and inserted using the recommended single-handed rotational technique. Subsequently, a manometer was used to inflate the cuff to 60 cm H2O. Receives: Device: Ambu aura-i LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Mean blood pressure
incidence of emergence hypertension
Measured: UP TO 1 HOURE
Secondary outcomes (4)
Measure Mean Heart rate
incidence of tachycardia or bradycardia with emergence.
Measured: UP TO 1 HOURE
successful placement of the airway device
Number of attempts needed for successful placement of the airway device
Measured: UP TO 1 HOURE
incidence of postoperative complication
incidence of postoperative sore throat , hoarseness
Measured: up to 24 hours
amount of fentanyl
by microgram
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Dec 2020
- Primary completion10 May 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, MalignantStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- Amr s wahdan, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582227
- Sponsor's protocol ID
- MD-202-2020
- Status last verified
- Jan 2024
- First submitted
- 3 Oct 2020
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Ambu Aura-i Laryngeal Mask Airway Versus Endotracheal Tube on Emergence Hypertension in Supratentorial Cranial Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04582227
- Acronym / sponsor ID
- MD-202-2020
- Conditions
- Hypertension, Malignant, Airway Management
- Keywords
- Hypertension, airway, Laryngeal Mask Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 9 Oct 2020 (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.
the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.
Detailed description
In this study the investigators want to assess the safety of using SGA devices in cranial surgery and comparing the effect of these devices with ETT regarding hemodynamics stability throughout the procedure and intracranial tension.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ETT group | – | –Oral endotracheal intubation via direct laryngoscopy will be performed. The ETT cuff will be inflated to 25 cmH2O using a manometer. |
| The LMA group | – | Device: Ambu aura-i LMAThe Ambu aura-i LMA size will be chosen and inserted using the recommended single-handed rotational technique. Subsequently, a manometer was used to inflate the cuff to 60 cm H2O. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged from 18 to 60 years presented with brain lesions undergoing craniotomies under general anaesthesia in supine position.
Key inclusion criteria (4 listed)
- Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position.
- Aged 18 to 60 years.
- ASA 1 or 2.
- GCS ≥ 13.
Key exclusion criteria (4 listed)
- Patients who are known hypertensive, history of cardiac diseases or chest diseases
- Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery).
- Risk of difficult intubation
- Extensive intracranial tumours that may affect recovery of patients.
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 |
|---|---|---|
| Ambu aura-i LMAThe ETT or the LMA will be inserted with the patient's head position is aided either by pins or head rest, and either the head will be in neutral position or tilted as long as the airway device is successfully placed. | Device | The LMA group |
Primary outcome
Measure Mean blood pressure
Time frame: UP TO 1 HOURE
incidence of emergence hypertension
4 secondary outcomes
Measure Mean Heart rate
Time frame: UP TO 1 HOURE
successful placement of the airway device
Time frame: UP TO 1 HOURE
incidence of postoperative complication
Time frame: up to 24 hours
amount of fentanyl
Time frame: up to 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 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Amr s wahdan, MD principal investigator
Cairo University
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 Hypertension, Malignant and Airway Management, run by Cairo 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 4 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 17 Jan 2024. 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?
Measure Mean blood pressure (time frame: UP TO 1 HOURE). 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 17 Jan 2024.