ObesityNCT03640442
Modified Ramped Position for Intubation of Obese Females.
A study testing Modified ramped position and Ramped position in people with Obesity and Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females in comparison to the traditional ramped position. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Anesthesia
- What is being tested?
- Modified ramped position and Ramped position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2018to 25 Apr 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients
- obese (with body mass index above 30 kg per squared meter)
- Scheduled for surgery under general anesthesia.
Who cannot join
- Patients with scars in the face or neck.
- Edentulous patients.
- Patients with airway masses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Ramped Position for Intubation of Obese Females: a Randomized Controlled Study
The aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females in comparison to the traditional ramped position.
Read the detailed description
Adequate conditions for endotracheal intubation require appropriate positioning of head and neck. The sniffing position had been described as the most appropriate head position for endotracheal intubation. Sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. Sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization.
In obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position. Some commercially available pillows were introduced to facilitate laryngoscopy in obese patients such as: Troop elevation pillow and Rapid airway management positioner.
In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese females; that is impedance of laryngoscopy by large breasts. This problem commonly hinders the intubation process and might lead to serious hypoxia. Most of the positions described in literature were concerned with facilitating laryngeal visualization. No position to the best of our knowledge was applied to aid the introduction of the laryngoscope in the presence of large breasts.
The investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head will be elevated using a head rest to achieve ordinary ramped position if laryngeal visualization was not adequate.
The aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.
- Conditions
- Obesity, Anesthesia
- Being tested
- Modified ramped position, Ramped position
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ramped positionOther
This position will be achieved using a special pillow. Shoulders will be elevated and neck will be extended to bring the breasts away from the laryngoscopy. The patient will be positioned so that the tip of the last spinous process (C7) will be at the edge of the pillow. The neck will be extended to the most possible range.
Ramped positionOther
This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus
| Study group | Role | What they receive |
|---|---|---|
| Modified ramped position group | Experimental | In this group, induction of anesthesia will be performed in the modified ramped position. Receives: Other: Modified ramped position |
| Ramped position group | Active comparator | In this group, induction of anesthesia will be performed in the ordinary ramped position. Receives: Other: Ramped position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of difficult laryngoscopy
defined as "failure to insert the laryngoscope in the oral cavity due to large breast with the need to reposition the patient to insert the laryngoscope"
Measured: 5 minutes after induction of general anesthesia
Secondary outcomes (6)
Time of laryngoscopy
Time measured in seconds from handling the laryngoscope till insertion of the whole blade length into the oral cavity
Measured: 5 minutes after induction of general anesthesia
Time till complete visualization of the vocal cords
Defined as the time measured in seconds from handling the laryngoscope till visualization of the vocal cords.
Measured: 5 minutes after induction of general anesthesia
Oxygen saturation
Oxygen saturation measured by pulse oximeter as percentage.
Measured: 5 minutes after induction of general anesthesia
End-tidal carbon dioxide
End-tidal carbon dioxide measured in mmhg by capnography
Measured: 5 minutes after induction of general anesthesia
Heart rate
Heart rate measured as number of heart beats per minute
Measured: 5 minutes after induction of general anesthesia
incidence of difficult mask ventilation
The incidence of difficult mask ventilation defined as the need for high force or the need for additional assistant for maintenance of adequate ventilation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start9 Sep 2018
- Primary completion20 Apr 2019
- Study completion25 Apr 2019
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 ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Hasanin, Professor, Principal investigator, Assistant professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640442
- Sponsor's protocol ID
- N-107-2018
- Status last verified
- Jun 2019
- First submitted
- 18 Aug 2018
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasanin A, Tarek H, Mostafa MMA, Arafa A, Safina AG, Elsherbiny MH, Hosny O, Gado AA, Almenesey T, Hamden GA, Mahmoud M, Amin S. Modified-ramped position: a new position for intubation of obese females: a randomized controlled pilot study. BMC Anesthesiol. 2020 Jun 17;20(1):151. doi: 10.1186/s12871-020-01070-2.
PubMed 32552691
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Ramped Position for Intubation of Obese Females: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03640442
- Acronym / sponsor ID
- N-107-2018
- Conditions
- Obesity, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 21 Aug 2018 (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 aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females in comparison to the traditional ramped position.
Detailed description
Adequate conditions for endotracheal intubation require appropriate positioning of head and neck. The sniffing position had been described as the most appropriate head position for endotracheal intubation. Sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. Sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization.
In obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position. Some commercially available pillows were introduced to facilitate laryngoscopy in obese patients such as: Troop elevation pillow and Rapid airway management positioner.
In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese females; that is impedance of laryngoscopy by large breasts. This problem commonly hinders the intubation process and might lead to serious hypoxia. Most of the positions described in literature were concerned with facilitating laryngeal visualization. No position to the best of our knowledge was applied to aid the introduction of the laryngoscope in the presence of large breasts.
The investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head will be elevated using a head rest to achieve ordinary ramped position if laryngeal visualization was not adequate.
The aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ramped position group | Experimental | Other: Modified ramped positionIn this group, induction of anesthesia will be performed in the modified ramped position. |
| Ramped position group | Active comparator | Other: Ramped positionIn this group, induction of anesthesia will be performed in the ordinary ramped position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients
- obese (with body mass index above 30 kg per squared meter)
- Scheduled for surgery under general anesthesia.
Key exclusion criteria (3 listed)
- Patients with scars in the face or neck.
- Edentulous patients.
- Patients with airway masses.
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 |
|---|---|---|
| Modified ramped positionThis position will be achieved using a special pillow. Shoulders will be elevated and neck will be extended to bring the breasts away from the laryngoscopy. The patient will be positioned so that the tip of the last spinous process (C7) will be at the edge of the pillow. The neck will be extended to the most possible range. | Other | Modified ramped position group |
| Ramped positionThis position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus | Other | Ramped position group |
Primary outcome
Incidence of difficult laryngoscopy
Time frame: 5 minutes after induction of general anesthesia
defined as "failure to insert the laryngoscope in the oral cavity due to large breast with the need to reposition the patient to insert the laryngoscope"
6 secondary outcomes
Time of laryngoscopy
Time frame: 5 minutes after induction of general anesthesia
Time till complete visualization of the vocal cords
Time frame: 5 minutes after induction of general anesthesia
Oxygen saturation
Time frame: 5 minutes after induction of general anesthesia
End-tidal carbon dioxide
Time frame: 5 minutes after induction of general anesthesia
Heart rate
Time frame: 5 minutes after induction of general anesthesia
incidence of difficult mask ventilation
Time frame: 5 minutes
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 24 Jun 2019.
- Derived from this study: PubMed 32552691Hasanin A, Tarek H, Mostafa MMA, Arafa A, Safina AG, Elsherbiny MH, Hosny O, Gado AA, Almenesey T, Hamden GA, Mahmoud M, Amin S. Modified-ramped position: a new position for intubation of obese females: a randomized controlled pilot study. BMC Anesthesiol. 2020 Jun 17;20(1):151. doi: 10.1186/s12871-020-01070-2.
- Individual participant dataSharing planned: No
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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.
Ahmed Hasanin, Professor principal investigator
Assistant professor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified ramped position and Ramped position in people with Obesity and Anesthesia, 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 3 inclusion and 3 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 24 Jun 2019. 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?
Incidence of difficult laryngoscopy (time frame: 5 minutes after induction of general anesthesia). 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 NCT03640442, 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 24 Jun 2019.