Guided Insertion Of Tracheostomy Tubes (GIFT): An Early Feasibility Study
NCT07929662, Not applicable, Not yet recruiting, Manchester University NHS Foundation Trust
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Guided Insertion Of Tracheostomy Tubes (GIFT): An Early Feasibility Study | ClinicalTrials.gov |
| NCT number | NCT07929662 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Manchester University NHS Foundation Trust | ClinicalTrials.gov |
| Conditions | Tracheostomy | ClinicalTrials.gov |
| Interventions | GIFT | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety Feasibility: Device deficiency that leads to a Serious Adverse Event | 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 | ClinicalTrials.gov |
| Primary | Usability Feasibility: System Usability Scale | 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. | ClinicalTrials.gov |
| Primary | Performance Feasibility: Procedural success | 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). | ClinicalTrials.gov |
| Secondary | Exploratory feasibility: Total PDT Time | 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). | ClinicalTrials.gov |
| Secondary | Exploratory feasibility: Needle Puncture Time | Perioperative/Periprocedural | Needle puncture time (time from first insertion of the needle to operator-declared successful needle insertion) | ClinicalTrials.gov |
| Secondary | Exploratory feasibility: Needle Insertions | Perioperative/Periprocedural | Number of needle insertions (one insertion is defined as the needle entering the skin and then being completely removed). | ClinicalTrials.gov |
| Secondary | Exploratory feasibility: Depth to tracheal target | Perioperative/Periprocedural | Depth to tracheal target (measured depth from skin to tracheal target sensor) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41743324 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)