Pilot Study of the Sage Guard for Oral Cavity Protection
Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity
The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A device will be placed in participants that are intubated in the ICU. The device will remain in place for up to 21 days, removal of the device will coincide with extubation. Surveys will be completed by experienced healthcare providers in the ICU to answer work related questions and provide a baseline for oral trauma in the ICU while intubated. Bedside nurses will be asked to answer questions about their experience with the device during participant use to understand ease of usability and integration into the workflow.
Studietype
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Intubated ICU patients on mechanical ventilation
- 2 sets of opposing teeth that occlude on both left and right sides
- Attending physician requested a dental evaluation as part of the patient's care
Exclusion Criteria:
- Active oral infection or trauma preventing safe device placement
- Known allergy to thermoplastic polyurethane (TPU)
- Severe facial or jaw trauma incompatible with device placement
- Mixed dentition, primary dentition, and edentulous patients
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sage Guard Intervention
Participants will wear the Sage Guard device during the study procedure to evaluate its feasibility, safety, usability, and effectiveness in protecting vital structures of the oral cavity. |
The study device is a single-use mouth device made of a soft plastic material (thermoplastic polyurethane). It has side bite blocks that help keep the teeth apart, a center support that helps hold the breathing tube in place, and tongue guards that help protect the tongue from injury. The device is designed for use in patients with an endotracheal (breathing) tube to help prevent injury to the mouth and tongue caused by biting and to help keep the breathing tube stable. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of oral trauma in intubated patients
Tidsramme: Daily assessment up to Day 21
|
The occurrence of oral injuries, including injury to the tongue, lips, cheeks, gums, or other oral tissues, during the period of endotracheal intubation. The incidence of oral trauma will be compared between patients managed with the study device and those receiving standard care. |
Daily assessment up to Day 21
|
|
Incidence of endotracheal tube displacement in intubated patients
Tidsramme: Daily assessment up to Day 21
|
The occurrence of endotracheal tube movement from its intended position during the period of intubation. The incidence of tube displacement will be compared between patients managed with the study device and those receiving standard care. |
Daily assessment up to Day 21
|
|
Incidence of endotracheal tube damage in intubated patients
Tidsramme: Daily assessment up to Day 21
|
The occurrence of endotracheal tube damage during the period of intubation. The incidence of tube damage will be compared between patients managed with the study device and those receiving standard care. |
Daily assessment up to Day 21
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of movement of study device position during endotracheal intubation
Tidsramme: Daily assessment up to Day 21
|
The occurrence of movement of the study device from its intended position during the period of endotracheal intubation. The frequency of device displacement events will be recorded. |
Daily assessment up to Day 21
|
|
Likert Scale Scores of study device use by bedside nursing staff
Tidsramme: Daily assessment up to Day 21
|
Feasibility will be assessed by nursing staff using a standardized questionnaire evaluating ease of device placement, maintenance, removal, and integration into routine patient care workflow. A Likert scale is scored by assigning numbers to each answer choice. You then add up or average these numbers to turn soft feelings into hard data. A standard five-point scale gives a score of 1 to 5 for each question - Higher totals mean more of that trait or feeling. |
Daily assessment up to Day 21
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Amir Taha, DDS, Obsolete Engineering Co.
- Hovedetterforsker: Jesus A. Valdez, DDS, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB00149615
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data (IPD) will not be shared. Due to the small sample size in this pilot feasibility study, sharing de-identified participant-level data could increase the risk of participant re-identification and compromise confidentiality.
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