Trial Outcomes & Findings for An MRI Study of the Sniffing, Neutral and Extended Head and Neck Positions (NCT NCT05002790)

Last Updated: 2024-08-28

Results Overview

To determine which patient head and neck positioning significantly improves the angle A. It is defined as the angle between the tracheal axis (TA) and laryngeal axis (LA)

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Each subject will undergo 3 MRI scans. Angle A will be measured on each scan at the end of all the scans performed that day. The angles will be measured by 2 investigators.

Results posted on

2024-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Data Collection All 20 anticipated subjects to be scanned under MRI, with data collected and analysed together Data collection group: Magnetic resonance imaging (MRI) allows measurement of the axes described to suggest which head and neck position would provide best anatomical alignment to reduce anterior impingement. All the MRI scans will be conducted using 3.0 Tesla (Optima 750w, GE Medical, Milwaukee, WI, USA) using the cervical spine section of the coil. T2-weighted images in the sagittal plane will be acquired using a fast recovery fast spin echo (FRFSE) technique. The scans will take around two and half minutes and a member of the anaesthetic investigator team will be present to facilitate positional changes and maintain consistency. MRI scanning will be performed in following 3 head and neck positions: Neutral position, Sniffing position and the Extension position.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An MRI Study of the Sniffing, Neutral and Extended Head and Neck Positions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Data Collection n=20 Participants All 20 anticipated subjects to be scanned under MRI, with data collected and analysed together Data collection group: Magnetic resonance imaging (MRI) allows measurement of the axes described to suggest which head and neck position would provide best anatomical alignment to reduce anterior impingement. All the MRI scans will be conducted using 3.0 Tesla (Optima 750w, GE Medical, Milwaukee, WI, USA) using the cervical spine section of the coil. T2-weighted images in the sagittal plane will be acquired using a fast recovery fast spin echo (FRFSE) technique. The scans will take around two and half minutes and a member of the anaesthetic investigator team will be present to facilitate positional changes and maintain consistency. MRI scanning will be performed in following 3 head and neck positions: Neutral position, Sniffing position and the Extension position.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.5 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Each subject will undergo 3 MRI scans. Angle A will be measured on each scan at the end of all the scans performed that day. The angles will be measured by 2 investigators.

Population: data from all participants was analysed

To determine which patient head and neck positioning significantly improves the angle A. It is defined as the angle between the tracheal axis (TA) and laryngeal axis (LA)

Outcome measures

Outcome measures
Measure	Neutral Position n=20 Participants participants positioned in neutral position	Sniffing Position n=20 Participants participants position din sniffing position	Extended Position n=20 Participants participants positioned in extended position
Angle A Measured on MRI	20.7 degree Standard Deviation 6.8	10.8 degree Standard Deviation 6.9	30.0 degree Standard Deviation 5.2

SECONDARY outcome

Timeframe: Each subject will undergo 3 MRI scans. The angles will be measured on each scan at the end of the scanning performed that day. The angles will be measured by 2 investigators.

The tracheal axis (TA) is defined as a line passing through the centre of intrathoracic part of trachea to the centre of cricoid cartilage. The laryngeal axes (LA) is defined as a line passing through the centre of cricoid cartilage to the base of the epiglottis. The pharyngeal axis (PA) is defined as a line passing through the anterior portion of the atlas and vertebrae C2. The oral axis (OA) is defined as straight line drawn parallel to the hard palate. The line of vision (LV) is defined as the straight line passing through the inferior extremity of the superior incisors and posterior extremity of the superior portion of the cricoid. Angle B is angle between the laryngeal axes (LA) and pharyngeal axes (LA) Angle C is angle between pharyngeal axes (PA) and oral axes (OA) Angle D angle between laryngeal axes (LA) and line of vision (LV) Angle E angle between line of vision (LV) and pharyngeal axes (PA)

Outcome measures

Outcome measures
Measure	Neutral Position n=20 Participants participants positioned in neutral position	Sniffing Position n=20 Participants participants position din sniffing position	Extended Position n=20 Participants participants positioned in extended position
Angle B, C, D and E Measured Using MRI Angle B	13.0 degree Standard Deviation 6.7	17.0 degree Standard Deviation 7.4	23.9 degree Standard Deviation 6.5
Angle B, C, D and E Measured Using MRI Angle C	87.8 degree Standard Deviation 6.4	69.5 degree Standard Deviation 7.2	81.7 degree Standard Deviation 6.0
Angle B, C, D and E Measured Using MRI Angle D	38.8 degree Standard Deviation 6.7	27.0 degree Standard Deviation 3.9	24.5 degree Standard Deviation 5.3
Angle B, C, D and E Measured Using MRI Angle E	51.3 degree Standard Deviation 5.7	43.8 degree Standard Deviation 6.0	48.4 degree Standard Deviation 5.0

Adverse Events

Data Collection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cyprian Mendonca

University Hospitals Coventry &Watwickshire NHS Trust

Phone: 02476964000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place