High BMINCT06889337
A Comparative Study of Supine Position and the Head Elevated Position on the Level of Sensory Block After Spinal Anesthesia in Morbidly Obese Parturient Undergoing Elective Cesarean Delivery
A study testing head elevated laryngoscopy position by Oxford pillow in people with High BMI, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The sniffing position defined as neck flexion with upper cervical extension, is traditionally recommended for general anesthesia induction, as it improves laryngoscopic views. However, the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High BMI
- What is being tested?
- head elevated laryngoscopy position by Oxford pillow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteQatar
- Study dates
- 1 May 2023to 10 Dec 2024
- 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
- Age 18yrs of age or more
- BMI 40 or more and more than or equal 37 weeks of gestation
- elective CD
- consented for neuraxial anesthesia
- singleton fetus
- ASA class 3 (no co-morbidities except morbid obesity, gestational diabetes, and gestational hypothyroidism)
Who cannot join
- Age <18 years
- BMI less than 39.9 and <37 weeks of gestation
- parturient preference for general anesthesia or contraindication to neuraxial anesthesia
- Women with comorbidities other than obesity, gestational diabetes or gestational hypothyroidism.
- women in active labor (>3 cm dilated with regular uterine contractions)
- emergency CD
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- Possible uterine over-distension or under-distension (e.g. polyhydramnios, estimated fetal weight >4 kg by ultrasound scan, or oligohydramnios or concern for fetal IUGR)
- maternal height <150 cm or >180 cm.
- Patients for which more than 2 minutes is taken in positioning after anesthesia induction (Time 0).
Trial locations and contacts
1 site in 1 country.
About this study
The sniffing position defined as neck flexion with upper cervical extension, is traditionally recommended for general anesthesia induction, as it improves laryngoscopic views. However, the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical,Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA)has been shown to not only increase respiratory reserve but also to improve laryngeal views in patients undergoing bariatric surgery. Additionally it helps in pre-oxygenating the patient more efficiently by keeping the airway patent and provides easier bag-mask ventilation.
It may also benefit the term parturient in a similar way by improving functional residual capacity (FRC), ventilation and comfort. However, this positon may affect the cephalad spread of the intrathecal local anesthetic.
Read more
Two earlier studies looked at the intrathecal local anesthetic spread in obstetric patients when placed in the head elevated laryngoscopy position, and both suggested poor cephalad spread, with patients requiring higher supplementation.
However, both studies excluded morbidly obese patients. The Investigators hypothesized that in obese parturients with BMI more than or equal 40, higher intra-abdominal pressures and possibly lower CSF volumes will counteract the poor cephalad spread associated with this position. The aim of this study is to determine the effect of a ramped position on intrathecal local anesthetic spread in the morbidly obese term parturients with BMI more than or equal 40 undergoing elective Cesarean delivery(CD).
- Conditions
- High BMI
- Being tested
- head elevated laryngoscopy position by Oxford pillow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head elevated laryngoscopy position by Oxford pillowOther
ramped position, also known as head elevated laryngoscopy position,
| Study group | Role | What they receive |
|---|---|---|
| HEAD ELEVATING LARYNGOSCOPY PILLOW | Experimental | the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical, Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA) Receives: Other: head elevated laryngoscopy position by Oxford pillow |
| Standard pillow group | No intervention | Standard pillow group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensory level (loss of cold and pin prick sensation) at 15 min after the intrathecal administration of the medication in the parturient
Measured: From date of randomization until the date of first documented progression, assessed up to 48 months
Secondary outcomes (1)
Incidence of inadequate block level at 15 min and need for epidural supplements
Secondary Outcomes:
- Incidence of inadequate block level at 15 min II. The need for epidural supplementation. III. Dosage of epidural local anesthetics to achieve adequate block level following the spinal anesthetic.
IV. The need and dosage of iv opioids for intraoperative supplemental analgesia V. The incidence of pain throughout the procedure (by the use of NRS). VI. The use and dosage of vasopressor. VII. The rate of conversion to general anesthesia. VIII. Maternal satisfaction with the position. IX. Neonatal outcomes (Birth weight in kilograms, APGAR scores, umbilical cord gases and lactate)
Measured: From date of randomization until the date of first documented progression, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 May 2023
- Primary completion11 Jul 2024
- Study completion10 Dec 2024
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 High BMIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total 90 patients will be enrolled in the study, 45 patients in each group.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889337
- Sponsor's protocol ID
- MRC-01-21-032
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elfil H, Afzal A, Valappil SS, Mathew GV, Mohammed WYA, Belghith N, Abdel-Rahman ME, Alhusban T. Comparison of supine vs head-elevated position on sensory block height following combined spinal epidural anaesthesia in Class III obese parturients undergoing elective caesarean delivery- a randomized controlled trial. BMC Anesthesiol. 2026 Mar 16;26(1):191. doi: 10.1186/s12871-026-03756-5.
PubMed 41840470
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Supine Position and the Head Elevated Position on the Level of Sensory Block After Spinal Anesthesia in Morbidly Obese Parturient Undergoing Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06889337
- Acronym / sponsor ID
- MRC-01-21-032
- Conditions
- High BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 21 Mar 2025 (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 sniffing position defined as neck flexion with upper cervical extension, is traditionally recommended for general anesthesia induction, as it improves laryngoscopic views. However, the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical,Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA)has been shown to not only increase respiratory reserve but also to improve laryngeal views in patients undergoing bariatric surgery. Additionally it helps in pre-oxygenating the patient more efficiently by keeping the airway patent and provides easier bag-mask ventilation.
It may also benefit the term parturient in a similar way by improving functional residual capacity (FRC), ventilation and comfort. However, this positon may affect the cephalad spread of the intrathecal local anesthetic.
Two earlier studies looked at the intrathecal local anesthetic spread in obstetric patients when placed in the head elevated laryngoscopy position, and both suggested poor cephalad spread, with patients requiring higher supplementation.
However, both studies excluded morbidly obese patients. The Investigators hypothesized that in obese parturients with BMI more than or equal 40, higher intra-abdominal pressures and possibly lower CSF volumes will counteract the poor cephalad spread associated with this position. The aim of this study is to determine the effect of a ramped position on intrathecal local anesthetic spread in the morbidly obese term parturients with BMI more than or equal 40 undergoing elective Cesarean delivery(CD).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total 90 patients will be enrolled in the study, 45 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| HEAD ELEVATING LARYNGOSCOPY PILLOW | Experimental | Other: head elevated laryngoscopy position by Oxford pillowthe head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical, Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA) |
| Standard pillow group | No intervention | –Standard pillow group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18yrs of age or more
- BMI 40 or more and more than or equal 37 weeks of gestation
- elective CD
- consented for neuraxial anesthesia
- singleton fetus
Key exclusion criteria (9 listed)
- Age <18 years
- BMI less than 39.9 and <37 weeks of gestation
- parturient preference for general anesthesia or contraindication to neuraxial anesthesia
- Women with comorbidities other than obesity, gestational diabetes or gestational hypothyroidism.
- women in active labor (>3 cm dilated with regular uterine contractions)
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 |
|---|---|---|
| head elevated laryngoscopy position by Oxford pillowramped position, also known as head elevated laryngoscopy position, | Other | HEAD ELEVATING LARYNGOSCOPY PILLOW |
Primary outcome
The sensory level (loss of cold and pin prick sensation) at 15 min after the intrathecal administration of the medication in the parturient
Time frame: From date of randomization until the date of first documented progression, assessed up to 48 months
1 secondary outcome
Incidence of inadequate block level at 15 min and need for epidural supplements
Time frame: From date of randomization until the date of first documented progression, assessed up to 48 months
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 21 Mar 2025.
- Derived from this study: PubMed 41840470Elfil H, Afzal A, Valappil SS, Mathew GV, Mohammed WYA, Belghith N, Abdel-Rahman ME, Alhusban T. Comparison of supine vs head-elevated position on sensory block height following combined spinal epidural anaesthesia in Class III obese parturients undergoing elective caesarean delivery- a randomized controlled trial. BMC Anesthesiol. 2026 Mar 16;26(1):191. doi: 10.1186/s12871-026-03756-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head elevated laryngoscopy position by Oxford pillow in people with High BMI, run by Hamad Medical Corporation at 1 site in Qatar.
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 6 inclusion and 9 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 21 Mar 2025. 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 Qatar. 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?
The sensory level (loss of cold and pin prick sensation) at 15 min after the intrathecal administration of the medication in the parturient (time frame: From date of randomization until the date of first documented progression, assessed up to 48 months). 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 NCT06889337, 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 21 Mar 2025.