Elective SurgeryNCT07506655
Comparison of Tracheal Intubation in Ramp vs Sniffing Position Using Customized vs Fixed Pillow
A study testing Group A - Fixed Pillow and Group B - Customized Pillow in people with Elective Surgery and General Anesthesia, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to find out whether the ramp position or sniffing position is better for endo tracheal intubation which provides better hemodynamic stability and short intubation time and good laryngoscopic view in regards of cormack lehane grading. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Elective Surgery, General Anesthesia
- What is being tested?
- Group A - Fixed Pillow and Group B - Customized Pillow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years
- ASA physical status I or II
- Mallampati class I or II
- Patients scheduled for elective surgery
- BMI between 25 and 30
- Either gender
Who cannot join
- ASA physical status III or IV
- Predicted difficult intubation (Mallampati class III or IV)
- Maxillofacial trauma, tumors, or obvious malformations of the neck or face
- Pregnancy
- Unstable cervical spine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Hemodynamic Stability and Intubation Timings and Cormack-Lehane Grading in Ramp Position Versus Sniffing Position
The goal of this clinical trial is to find out whether the ramp position or sniffing position is better for endo tracheal intubation which provides better hemodynamic stability and short intubation time and good laryngoscopic view in regards of cormack lehane grading.
Read the detailed description
This randomized controlled trial will be conducted at the Shaheed Mohtarma Benazir Bhutto Institute of Trauma after obtaining approval from the College of Physicians and Surgeons of Pakistan (CPSP) and the Ethical Review Committee. The study will also be registered on ClinicalTrials.gov prior to participant enrollment.
Participants will be allocated into two groups using computer-generated randomization. Group A will undergo tracheal intubation in the sniffing position using a fixed pillow height of 4 cm, while Group B will be positioned in the ramp position using a customized pillow height (4-8 cm) adjusted to achieve alignment of the external auditory meatus with the sternal notch. Allocation will be performed by the primary investigator prior to surgery.
All patients will receive a standardized anesthesia protocol with continuous ASA monitoring. Induction of anesthesia will be achieved using propofol (2 mg/kg) and nalbuphine (0.15 mg/kg), followed by atracurium (0.5 mg/kg) after confirmation of adequate mask ventilation. Controlled positive pressure ventilation will be maintained for three minutes before direct laryngoscopy using a Macintosh laryngoscope.
Laryngoscopy will be performed by the primary investigator, while a second anesthetist, blinded to the study objectives where feasible, will record procedural timings and hemodynamic parameters. Any adjuncts or optimization maneuvers used during intubation will be documented. Hemodynamic variables will be monitored at predefined intervals following intubation.
The study will be conducted as an open-label trial. All patient data will be handled confidentially, and anonymization will be ensured during data collection, analysis, and reporting.
- Conditions
- Elective Surgery, General Anesthesia
- Being tested
- Group A - Fixed Pillow, Group B - Customized Pillow
- Keywords
- Airway management, Sniffing position, Ramp position, Tracheal intubation, Pillow height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A - Fixed PillowDevice
Fixed pillow height of 4 cm for laryngoscopy alignment
Group B - Customized PillowDevice
Pillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Fixed Pillow | Experimental | Participants receive a fixed pillow height of 4 cm to align the head for laryngoscopy. Receives: Device: Group A - Fixed Pillow |
| Group B - Customized Pillow | Experimental | Participants receive a customized pillow height of 4-8 cm to align the external auditory meatus and sternal notch. Receives: Device: Group B - Customized Pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Attempt Intubation Success Rate
Percentage of patients in whom successful intubation is achieved on the first attempt using the study device.
Measured: During the procedure
Secondary outcomes (4)
Heart Rate
Heart rate measured to assess physiological response to intubation. Units of Measure: Beats per minute (bpm)
Measured: 0, 3, and 5 minutes after intubation
Intubation Time
Total time taken for successful endotracheal intubation, including multiple attempts if necessary.
Measured: Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂)
Blood Pressure
Systolic and diastolic blood pressure measured to assess physiological response. Units of Measure: mmHg
Measured: 0, 3, and 5 minutes after intubation
Cormack-Lehane Grade
Laryngeal view graded according to the Cormack-Lehane classification by the primary investigator.
Measured: During laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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 Elective SurgeryStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: Group A (fixed pillow height of 4 cm) or Group B (customized pillow height 4-8 cm to align the external auditory meatus and sternal notch). The study will compare laryngoscopy view and intubation time between the two groups. Randomization is computer-generated, and all patients will undergo a standardized anesthesia protocol. Outcome data, including Cormack-Lehane grade, intubation time, and hemodynamic parameters, will be recorded.
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shafaq Memon, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Investigators
- Dr Zafar Mehdi, Fcps anaesthesiology, Study director, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506655
- Sponsor's protocol ID
- IRB-000178/SMBBIT/Approval/25
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Patient confidentiality, institutional policies, and local regulations regarding personal health information prevent sharing of the raw data.
Publications
Okada Y, Nakayama Y, Hashimoto K, Koike K, Watanabe N. Ramped versus sniffing position for tracheal intubation: A systematic review and meta-analysis. Am J Emerg Med. 2021 Jun;44:250-256. doi: 10.1016/j.ajem.2020.03.058. Epub 2020 Apr 1.
PubMed 32276812
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Stability and Intubation Timings and Cormack-Lehane Grading in Ramp Position Versus Sniffing Position
- ClinicalTrials.gov ID
- NCT07506655
- Acronym / sponsor ID
- IRB-000178/SMBBIT/Approval/25
- Conditions
- Elective Surgery, General Anesthesia
- Keywords
- Airway management, Sniffing position, Ramp position, Tracheal intubation, Pillow height
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Apr 2026 (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 goal of this clinical trial is to find out whether the ramp position or sniffing position is better for endo tracheal intubation which provides better hemodynamic stability and short intubation time and good laryngoscopic view in regards of cormack lehane grading.
Detailed description
This randomized controlled trial will be conducted at the Shaheed Mohtarma Benazir Bhutto Institute of Trauma after obtaining approval from the College of Physicians and Surgeons of Pakistan (CPSP) and the Ethical Review Committee. The study will also be registered on ClinicalTrials.gov prior to participant enrollment.
Participants will be allocated into two groups using computer-generated randomization. Group A will undergo tracheal intubation in the sniffing position using a fixed pillow height of 4 cm, while Group B will be positioned in the ramp position using a customized pillow height (4-8 cm) adjusted to achieve alignment of the external auditory meatus with the sternal notch. Allocation will be performed by the primary investigator prior to surgery.
All patients will receive a standardized anesthesia protocol with continuous ASA monitoring. Induction of anesthesia will be achieved using propofol (2 mg/kg) and nalbuphine (0.15 mg/kg), followed by atracurium (0.5 mg/kg) after confirmation of adequate mask ventilation. Controlled positive pressure ventilation will be maintained for three minutes before direct laryngoscopy using a Macintosh laryngoscope.
Laryngoscopy will be performed by the primary investigator, while a second anesthetist, blinded to the study objectives where feasible, will record procedural timings and hemodynamic parameters. Any adjuncts or optimization maneuvers used during intubation will be documented. Hemodynamic variables will be monitored at predefined intervals following intubation.
The study will be conducted as an open-label trial. All patient data will be handled confidentially, and anonymization will be ensured during data collection, analysis, and reporting.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: Group A (fixed pillow height of 4 cm) or Group B (customized pillow height 4-8 cm to align the external auditory meatus and sternal notch). The study will compare laryngoscopy view and intubation time between the two groups. Randomization is computer-generated, and all patients will undergo a standardized anesthesia protocol. Outcome data, including Cormack-Lehane grade, intubation time, and hemodynamic parameters, will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Group A - Fixed Pillow | Experimental | Device: Group A - Fixed PillowParticipants receive a fixed pillow height of 4 cm to align the head for laryngoscopy. |
| Group B - Customized Pillow | Experimental | Device: Group B - Customized PillowParticipants receive a customized pillow height of 4-8 cm to align the external auditory meatus and sternal notch. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 60 years
- ASA physical status I or II
- Mallampati class I or II
- Patients scheduled for elective surgery
- BMI between 25 and 30
Key exclusion criteria (5 listed)
- ASA physical status III or IV
- Predicted difficult intubation (Mallampati class III or IV)
- Maxillofacial trauma, tumors, or obvious malformations of the neck or face
- Pregnancy
- Unstable cervical spine
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 |
|---|---|---|
| Group A - Fixed PillowFixed pillow height of 4 cm for laryngoscopy alignment | Device | Group A - Fixed Pillow |
| Group B - Customized PillowPillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy. | Device | Group B - Customized Pillow |
Primary outcome
First-Attempt Intubation Success Rate
Time frame: During the procedure
Percentage of patients in whom successful intubation is achieved on the first attempt using the study device.
4 secondary outcomes
Heart Rate
Time frame: 0, 3, and 5 minutes after intubation
Intubation Time
Time frame: Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂)
Blood Pressure
Time frame: 0, 3, and 5 minutes after intubation
Cormack-Lehane Grade
Time frame: During laryngoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 32276812Okada Y, Nakayama Y, Hashimoto K, Koike K, Watanabe N. Ramped versus sniffing position for tracheal intubation: A systematic review and meta-analysis. Am J Emerg Med. 2021 Jun;44:250-256. doi: 10.1016/j.ajem.2020.03.058. Epub 2020 Apr 1.
- Ramped versus sniffing position for endo tracheal intubationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Patient confidentiality, institutional policies, and local regulations regarding personal health information prevent sharing of the raw data.
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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.
Dr Zafar Mehdi, Fcps anaesthesiology study director
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A - Fixed Pillow and Group B - Customized Pillow in people with Elective Surgery and General Anesthesia, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
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 5 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: enrolling by invitation, as of the sponsor's last update on 16 Sep 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
First-Attempt Intubation Success Rate (time frame: During the procedure). 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 NCT07506655, 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 16 Sep 2026.