NCT07251530 Communication Enhancement Among Ventilated Patients in Intensive Care
| NCT ID | NCT07251530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Critical Care, Intensive Care |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-03-19 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Intensive care is a unit that admits ventilated patients. Hospitalization is extremely challenging for these patients. Their vital prognosis is at stake, and they often have difficulty moving due to pain, edema, neuromyopathy, or the presence of monitoring cables. They are also hindered in their communication: they cannot speak because of the presence of the intubation tube between their vocal cords or the tracheostomy cannula with the inflated cuff. Every day, in each intensive care unit, about 50% of ventilated patients are conscious and face communication difficulties. They describe this difficulty as a "nightmare." This leads to challenges in care management and increases the anxiety caused by hospitalization in the intensive care unit. A large proportion of patients will develop post-intensive care syndrome. The tools currently used are not efficient. Moreover, many patients have comprehension difficulties due to the medications administered to them (sedatives) or due to the initial or secondary pathologies related to their hospitalization (confusional syndrome, ICU delirium). Our objective is to implement an adapted and personalized communication tool for ventilated patients in intensive care.
Eligibility Criteria
Inclusion Criteria: * Intubated ventilated ICU patient * Hospitalized patient with an inflated cuff tracheostomy * conscious patient, able to open and close eyes on demand * of-age patient * French speaking Exclusion Criteria: * Patient with uncorrected visual impairment or hearing deficiency * Known guardianship or trusteeship at the time of inclusion * Known pregnant women at the time of inclusion and lactating patients * opposed to the processing of personal data
Contact & Investigator
Laetitia BODET-CONTENTIN, MD PhD
PRINCIPAL INVESTIGATOR
Intensive care, University Hospital, Tours
Frequently Asked Questions
Who can join the NCT07251530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Care, Intensive Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07251530 currently recruiting?
Yes, NCT07251530 is actively recruiting participants. Contact the research team at laetitia.bodet@chu-tours.fr for enrollment information.
Where is the NCT07251530 trial being conducted?
This trial is being conducted at Le Mans, France, Orléans, France, Tours, France.
Who is sponsoring the NCT07251530 clinical trial?
NCT07251530 is sponsored by University Hospital, Tours. The principal investigator is Laetitia BODET-CONTENTIN, MD PhD at Intensive care, University Hospital, Tours. The trial plans to enroll 60 participants.