Guided Insertion Of Tracheostomy Tubes (GIFT): An Early Feasibility Study

\*\*Background and rationale\*\*

Percutaneous dilatational tracheostomy (PDT) is commonly performed in intensive care units (ICUs) for patients requiring prolonged mechanical ventilation. Accurate placement of the initial needle into the trachea is a critical step in the procedure. Incorrect positioning can result in bleeding, injury to the trachea or adjacent structures, failed insertion or other complications.

Conventional PDT relies on anatomical landmarks, clinical judgement and bronchoscopic guidance. However, these techniques do not provide continuous quantitative information about the position of the needle relative to the intended anatomical target. Needle placement can be particularly challenging in patients with difficult neck anatomy, obesity or poorly defined anatomical landmarks.

Guided Insertion for Tracheostomy (GIFT) is an investigational electromagnetic guidance system developed to provide real-time positional information during needle insertion. The system uses electromagnetic sensors to track the needle relative to a predefined target within the trachea, providing additional visual guidance to the operator.

Preclinical development has included technical verification, environmental testing, usability evaluation and anatomical validation. This study represents the first clinical evaluation of GIFT in humans.

\*\*Study design and objectives\*\*

This is a prospective, single-arm, non-blinded, first-in-human early feasibility study conducted in intensive care units at Manchester University NHS Foundation Trust.

The study will recruit between 30 and 40 adult participants requiring PDT as part of their routine clinical care.

The investigation will assess three principal feasibility domains:

1. Safety of the investigational device during clinical use.
2. Usability of the GIFT system by healthcare professionals.
3. Procedural performance, particularly the accuracy of needle placement.

Additional objectives include evaluating the technical reliability of the hardware and software, the practicality of integrating GIFT into established ICU workflows, procedural efficiency and acceptability to clinical staff.

The study is not randomised and does not include a concurrent control group. All participants undergoing the intervention will receive GIFT-assisted PDT.

A separately approved observational study will collect information about conventional PDT and surgical tracheostomy. Where appropriate, these data may provide contextual information for exploratory comparisons. The observational study is independent of the GIFT clinical investigation.

\*\*Investigational device and clinical procedure\*\*

The GIFT prototype uses an electromagnetic field and miniature sensors to determine the position of the PDT needle relative to an anatomical target within the trachea.

The system comprises an electromagnetic field generator, disposable sensors, a control unit and software that displays positional guidance to the operator.

Before the procedure, trained staff will prepare and verify the system according to the device instructions for use.

During PDT, a target sensor identifies the intended needle insertion position within the trachea. The GIFT system tracks the position of the insertion needle relative to this target and displays guidance to assist the operator.

The procedure will otherwise follow established bronchoscopy-assisted PDT practice. Bronchoscopic visualisation, anatomical assessment and clinical judgement remain essential throughout.

The operator may discontinue GIFT guidance if the device does not function as expected, if positional information is unreliable or if continued use is considered clinically inappropriate. The procedure may then continue using standard techniques.

GIFT is intended to supplement existing procedural guidance rather than replace bronchoscopy or clinical decision-making.

\*\*(1) Safety evaluation\*\*

Safety is a principal feasibility outcome of the investigation.

The primary procedural safety assessment period extends from the start of PDT until 24 hours after the procedure begins.

During this period, the research team will systematically document relevant adverse events, serious adverse events, adverse device effects, device deficiencies and system failures.

Events will be assessed for seriousness, expectedness, clinical significance and their possible relationship to the investigational device.

Particular attention will be given to device-related problems, including inaccurate positional guidance, loss of electromagnetic tracking, interference affecting system performance and difficulties interpreting the displayed information.

Relevant device-related adverse events and safety concerns identified after the initial 24-hour period will continue to be recorded throughout the participant's ICU admission.

The study incorporates predefined safety monitoring and suspension criteria.

A Trial Safety and Steering Committee, with an independent Chair, will review participant safety, device-related risks and emerging safety information. The committee will make recommendations to the Sponsor and Chief Investigator concerning continuation, modification, suspension or termination of the investigation.

\*\*(2) Healthcare professional usability evaluation\*\*

Usability will be assessed using the System Usability Scale (SUS), a validated questionnaire that measures perceived ease of use.

Following GIFT-assisted procedures, the PDT operator, airway operator and bedside nurse will be invited to complete the SUS questionnaire.

Scores will be summarised across completed questionnaires, including analyses by professional role. The number of individual respondents and completed questionnaires will be reported separately because some staff may participate in multiple procedures.

A study-specific questionnaire, known as FLOW, will also collect feedback from healthcare professionals involved in the procedure.

FLOW explores practical aspects of GIFT use, including equipment preparation, perceived procedural safety, potential delays, workflow integration and concerns about possible future applications.

Responses will be analysed descriptively to identify practical difficulties, potential improvements and factors relevant to future clinical implementation.

\*\*Feasibility outcomes\*\*

The study will evaluate the feasibility of the GIFT system across three domains:

1. Safety of the investigational device during clinical use.
2. Usability of the GIFT system by healthcare professionals.
3. Procedural performance, particularly the accuracy of needle placement.

\*\*(3) Procedural performance assessment\*\*

The principal procedural performance measure is the accuracy of needle placement relative to the predefined anatomical target.

Accuracy is expressed as the Distance from Target (DFT), measured in millimetres between the actual needle entry point and the intended insertion target. Successful GIFT-guided needle placement is defined as achieving a DFT of 9.4 mm or less.

Procedural performance will be evaluated using the proportion of attempted GIFT-assisted procedures that meet this threshold.

The analysis will include all procedures in which GIFT deployment or guidance was attempted. Failure to deploy the device, inability to use the guidance system or abandonment of GIFT guidance will be classified as procedural failure.

Missing DFT measurements will be reported separately, and sensitivity analyses will explore their potential influence on the estimated procedural success rate.

Additional procedural information will include the number of needle insertion attempts, procedure duration, technical difficulties and interruptions to normal clinical workflow.

\*\*Exploratory feasibility outcomes\*\*

The study will collect additional information to describe procedural efficiency and the subsequent clinical course of participants.

Exploratory assessments will include procedural timing, technical performance, complications, duration of mechanical ventilation and length of stay in intensive care.

Where available, hospital length of stay and relevant recovery milestones will also be recorded.

These data will help researchers identify suitable outcomes for future comparative studies.

Exploratory comparisons with conventional tracheostomy practice may be undertaken using information from the separately approved observational study. Such comparisons will be interpreted cautiously because participants are not randomised and differences between groups may influence the findings.

\*\*Consent and participant follow-up\*\*

Most eligible participants are expected to lack capacity to provide informed consent at the time of tracheostomy because of their critical illness and the need for sedation.

The study will therefore use arrangements for research involving adults lacking capacity, in accordance with the Mental Capacity Act 2005 and the procedures approved by the Research Ethics Committee.

Where practicable, advice will be sought from a Personal Consultee or, where appropriate, a Nominated Consultee before enrolment.

A deferred consent process will apply where permitted by the approved study procedures.

Participants who subsequently regain capacity will be informed about the investigation and invited to provide consent for continued participation and use of previously collected information.

Clinical decisions about whether and when to perform tracheostomy will remain the responsibility of the treating clinical team and will not be determined by the research.

Participants will be followed throughout their ICU admission, with relevant procedural, safety and clinical outcome data recorded according to the study protocol.

\*\*Feasibility assessment and progression criteria\*\*

The study uses prospectively defined Red-Amber-Green (RAG) criteria to assess whether the GIFT system is sufficiently safe, usable and accurate to support further clinical development.

Safety feasibility will be evaluated according to predefined criteria reflecting the occurrence and clinical significance of device-related adverse events, device deficiencies and potentially serious near-miss events.

Usability will be classified according to the mean SUS score:
* Green: 70 or higher.
* Amber: 50 to less than 70.
* Red: Below 50.

For procedural performance, the proportion of successful GIFT-assisted procedures will be classified as:
* Green: 80% or more achieve successful needle placement.
* Amber: 60% to less than 80% achieve successful needle placement.
* Red: Less than 60% achieve successful needle placement.

The three feasibility domains will be considered collectively. The RAG classifications will inform decisions about further development rather than automatically determining whether the device should progress.

Safety concerns will take precedence when determining whether modifications, further evaluation or discontinuation of development are appropriate.

\*\*Statistical analysis\*\*

The study is designed to estimate feasibility outcomes and identify potential barriers to further clinical investigation rather than demonstrate superiority over standard PDT.

Procedural success will be calculated as the proportion of attempted GIFT-assisted procedures achieving the predefined accuracy threshold.

Results will be presented using descriptive statistics and measures of uncertainty appropriate to the outcome.

Safety events and device deficiencies will be summarised by type, seriousness, clinical significance and relationship to GIFT.

Usability scores will be summarised overall and by professional role, acknowledging repeated assessments from individual healthcare professionals.

Exploratory analyses will describe procedural efficiency, technical reliability and clinical outcomes.

The overall feasibility assessment will integrate findings across safety, usability and procedural performance to determine whether the results support progression to subsequent clinical investigations.

\*\*Anticipated contribution\*\*

This first-in-human study will provide preliminary clinical evidence concerning the feasibility of electromagnetic guidance during PDT.

It will establish whether GIFT can provide sufficiently accurate positional guidance during routine ICU tracheostomy procedures, whether its use introduces unacceptable safety concerns and whether clinicians can integrate the technology into established practice.

The findings will guide further technical development, refinement of clinical workflows and the design of future comparative studies.

The investigation is not designed to demonstrate that GIFT reduces complications, shortens ICU admission or improves clinical outcomes compared with conventional tracheostomy. These potential benefits will require evaluation in subsequent clinical investigations.

Participants will undergo percutaneous dilatational tracheostomy (PDT) using the investigational Guided Insertion for Tracheostomy (GIFT) electromagnetic guidance system alongside standard bronchoscopic guidance. GIFT uses miniature electromagnetic sensors to track the position of the insertion needle relative to a predefined target within the trachea, providing real-time visual guidance to the operator. All procedures will follow established ICU PDT practice, with GIFT providing supplementary positional information. Clinical judgement and bronchoscopic visualisation remain essential. If GIFT guidance is unavailable, unreliable or clinically inappropriate, the operator may discontinue its use and proceed using standard techniques. Device safety, usability, technical performance and needle placement accuracy will be evaluated.

Device: GIFT

Participants will undergo percutaneous dilatational tracheostomy (PDT) using the investigational Guided Insertion for Tracheostomy (GIFT) electromagnetic guidance system alongside standard bronchoscopic guidance. GIFT uses miniature electromagnetic sensors to track the position of the insertion needle relative to a predefined target within the trachea, providing real-time visual guidance to the operator. All procedures will follow established ICU PDT practice, with GIFT providing supplementary positional information. Clinical judgement and bronchoscopic visualisation remain essential. If GIFT guidance is unavailable, unreliable or clinically inappropriate, the operator may discontinue its use and proceed using standard techniques. Device safety, usability, technical performance and needle placement accuracy will be evaluated.

Time frame: Perioperative/Periprocedural

Device deficiencies that lead to Serious Adverse Events (SAE). SAE is defined in the protocol by Medical Device Regulations. SAE's are defined as any untoward medical occurrence that:

• Results in death
• Is life-threatening
• Requires In-patient hospitalization or prolongation of existing hospitalization\*\*
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect
• Is otherwise considered medically significant by the investigator

Time frame: Perioperative/Periprocedural

System Usability Scale (SUS Questionnaire)

SUS Questionnaire is completed by PDT Operator, Airway Operator and Bedside Nurse after each GIFT-PDT procedure.

• Perceived ease of use
• Perceived complexity
• Learnability
• Overall system usability

Total SUS scores (calculated). Score is out of 100 where 0 is the least usable and 100 is the most usable. Using the validated SUS sclae allows the investigators to compare with published typical scores for new technology in general, and for new technologies introduced into critical care.

Time frame: Perioperative/Periprocedural

Procedural success is defined as use of the GIFT System to guide insertion of the PDT needle into the trachea where distance from target is within the clinically acceptable range.

Clinically acceptable range for GIFT-PDT is a distance from target ≤9.4mm. Distance from target (mm) is the distance between the optimal insertion point and the actual insertion point of the PDT needle.

The lower the distance from target, the better (more accurate).

Time frame: Perioperative/Periprocedural

Total PDT time (time from procedure start (the team brief or "time out") to removal of the sterile drape that signifies the end of the PDT procedure).

Time frame: Perioperative/Periprocedural

Needle puncture time (time from first insertion of the needle to operator-declared successful needle insertion)

Time frame: Perioperative/Periprocedural

Number of needle insertions (one insertion is defined as the needle entering the skin and then being completely removed).

Time frame: Perioperative/Periprocedural

Depth to tracheal target (measured depth from skin to tracheal target sensor)

Guided Insertion Of Tracheostomy Tubes (GIFT): An Early Feasibility Study