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Search / Trial NCT06977555

Communication With Mechanically Ventilated Intensive Care Patients

Launched by OSLO UNIVERSITY HOSPITAL · May 14, 2025

Trial Information

Current as of September 25, 2025

Enrolling by invitation

Keywords

Mechanically Ventilated Patients Delir Symptoms Self Efficacy

ClinConnect Summary

This study, called COMMEC-ICU, tests a training program for ICU nurses to help them communicate better with adults who are on life-support breathing machines. It’s a multicenter project in five ICUs at two university hospitals in Norway. Nurses will take a multi‑module course, and researchers will compare things before and after the training to see if patient communication improves, and if nurses feel more skilled and satisfied with their work. The study will look at both patient experiences and nurse skills, using several related measures.

Who can join: adults 18 or older who are in the ICU for the first time and have invasive mechanical ventilation for at least 2 days, who are awake or only mildly sedated and can consent, and who can understand Norwegian. Nurses with at least one year of ICU experience can participate as well. Some patients with delirium may also be included. Participants will be followed to see how well communication works for patients and how nurses’ skills and satisfaction change after the training. This is a training study, not a drug trial, and it is not randomized. The study is ongoing and aims to enroll up to about 500 participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria patients:
  • Patients over the age of 18
  • First ICU admission during the hospital stay
  • Cognitively competent at the time of consenting to participate
  • Invasive mechanical ventilation via endotracheal tube or tracheostomy for over 48 hours or more calendar days
  • Patients must have been reported awake and communicative or with a Richmond Agitation and Sedation scale over - 1.
  • Exclusion Criteria patients:
  • Patients who cannot understand Norwegian
  • Patients without an address
  • Patients who have cognitive disabilities and are not able to consent or receive information about the study
  • Inclusion criteria nurses: having clinical experience from the ICU for more than a year.

About Oslo University Hospital

Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.

Locations

Oslo, Norway

Patients applied

0 patients applied

Trial Officials

Tone Rustøen, PhD

Principal Investigator

OUS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported