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Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

13 luglio 2026 aggiornato da: Jennifer Cahill, Massachusetts General Hospital

A Randomized Controlled Trial of a Hospital-Grade Weighted Blanket to Improve Sedation Quality During Ventilator Weaning in the Blake 7 MICU (MGH)

Patients in the ICU who are being taken off of a breathing machine (ventilator weaning) commonly experience anxiety, agitation, sleep disruption, and physiologic stress. Weighted blankets have been used to improve patient comfort; however, the design of standard weighted blankets can interfere with the ICU environment and are often not adaptable to individual patient needs. This study will evaluate a weighted blanket specifically designed for ICU use, with features that allow adjustable weight and flexible configuration (e. g., full body, shoulder, or lap).

This study aims to determine whether the ICU-adapted weighted blanket:

  • Improves sedation quality, measured using the Richmond Agitation-Sedation Scale (RASS), which is already part of routine ICU care
  • Helps patients stay in a light, comfortable level of sedation during ventilator weaning
  • Is safe, feasible, and acceptable for use in the ICU environment

Participants will be randomly assigned (like flipping a coin) to one of two groups:

  • Weighted blanket group, or
  • Standard linen group

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

To help manage symptoms and discomfort while patients are being taken off of a breathing machine (ventilator weaning), patients are often treated with sedative medications to keep them calm or sleepy. While these medications are often necessary, they can sometimes lead to problems such as needing the breathing machine for longer, confusion (delirium), poor sleep, and longer stays in the ICU. Current ICU practice aims to use lighter levels of sedation when possible. As sedation is reduced, there is a need for safe, low-risk, non-medication approaches that help keep patients comfortable without affecting their alertness or breathing.

Previous studies suggest that weighted blankets may reduce anxiety and physiologic stress without negatively affecting vital signs. However, the standard design of commercially available weighted blankets can affect their safety and usability. These include materials and construction that are not ideal for hospital use, excessive heat retention, special washing requirements, limited ability to adjust blanket weight, and interference with medical lines, tubes, and equipment.

These observations, along with clinician feedback, informed the development of a hospital-grade weighted blanket designed specifically for ICU use. This weighted blanket allows the amount of weight to be adjusted (5-20 pounds) and can be applied in different ways (e. g., over the full body, on the shoulders, or on the lap) depending on patient needs. It is designed to work safely alongside standard hospital equipment and fits within routine ICU care.

This study will compare the use of this weighted blanket to standard hospital linens to understand whether this weighted blanket improves patient comfort. This study is a randomized controlled trial in which participants are randomly assigned to receive either (1) the weighted blanket or (2) standard hospital linens. The study will enroll 64 patients. Participants will remain in the study until removal of mechanical ventilation (extubation). All data collected are part of routine care, and patient care will not be altered by study participation.

The trial will take place at the Blake 7 Medical Intensive Care Unit at Massachusetts General Hospital.

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥18 years
  • Intubated and mechanically ventilated
  • Receiving sedation and/or analgesia
  • Documented clinical decision to initiate ventilator weaning
  • Patient or legally authorized representative (LAR)/healthcare proxy (HCP) able to provide informed consent

Exclusion Criteria:

  • Conditions in which deep pressure / blanket application may compromise safety in the opinion of the treating clinical team
  • Braden Scale score ≤9 with evidence of significant skin compromise
  • Patients with pre-existing pressure injuries on posterior, weight-bearing body surfaces (e.g., sacrum, coccyx, heels) will be excluded
  • Recent major surgery or unstable fractures affecting the torso
  • Continuous prone positioning
  • Body mass index ≥35 kg/m² as a precautionary exclusion due to uncertainty regarding pressure distribution and respiratory mechanics during early feasibility testing
  • Concurrent enrollment in another interventional trial affecting sedation or ventilation
  • Anticipated withdrawal of life-sustaining therapy
  • Pregnant individuals in the 2nd or 3rd trimester

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Weighted blanket
The intervention group will receive the hospital-grade weighted blanket, to add on to usual care.
Dispositivo: Weighted blanket

For participants in the weighted blanket group:

  • ICU nursing staff will place a hospital grade weighted blanket on the patient during ventilator weaning
  • The blanket will weigh approximately 10% of the patient's body weight, with a maximum weight of 20 pounds.
  • The blanket's weight may be adjusted as needed. The blanket is composed of individual squares weighing about 5 pounds each. These squares can be attached to form composite blankets with total weights of 10, 15, or 20 pounds
  • The blanket may be used in different configurations (full body, shoulder, or lap) based on the patient's tolerance and the nursing staff's clinical judgment
  • The blanket does not restrict movement, airway access, or routine medical care
  • Nursing staff may remove the blanket at any time for comfort, safety, procedures, or clinical reasons
Comparatore fittizio: Standard hospital linens
The control group will receive standard hospital bedding, which is part of usual care.
Dispositivo: Standard hospital linens

For participants in the standard hospital linens group:

  • Participants will receive standard hospital bedding during ventilator weaning. This is part of standard care for patients in the ICU
  • Bedding will be managed by ICU nursing staff according to routine clinical practice

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sedation quality
Lasso di tempo: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.

Sedation and agitation will be measured using the Richmond Agitation-Sedation Scale (RASS). This scale ranges from +4 (combative) to -5 (unarousable), with 0 indicating an alert and calm state. Positive scores reflect agitation and negative scores reflect increasing levels of sedation.

Sedation quality is defined as the proportion of time patients spend within a goal RASS score, between 0 to +1, during ventilator weaning. This range reflects intended light sedation during ventilator weaning to preserve alertness and respiratory drive.
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of study
Lasso di tempo: From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Acceptability will be defined as less than or equal to 33% blanket rejection rate by patients. Blanket rejection will consist of patient or clinician request for the blanket to be permanently removed.
From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Sedative and analgesic exposure
Lasso di tempo: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Measured total amount of sedation and analgesia received from time weaning initiated to extubation, normalized per weight and time on study. Dose and frequency data will be derived from routine clinical documentation in the Epic Medication Administration Record (EPIC MAR).
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Time to extubation
Lasso di tempo: From initiation of ventilator weaning until extubation, assessed for up to two weeks.
The time between ventilator weaning and extubation will be derived from Epic nursing flowsheets.
From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Delirium incidence
Lasso di tempo: Daily from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Delirium will be assessed when RASS scores range between -1 to +1, using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU evaluates acute onset or fluctuating mental status, inattention, altered level of consciousness, and disorganized thinking. Delirium will be defined as present when features 1 and 2, plus either feature 3 or 4, are positive. Delirium incidence will be recorded as a binary outcome (present/absent) during the study period.
Daily from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Pain severity
Lasso di tempo: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Pain will be assessed using the Critical-Care Pain Observation Tool (CPOT) in patients unable to self-report. The tool includes four domains: facial expression, body movements, muscle tension, and compliance with the ventilator (or vocalization in non-intubated patients), each scored from 0 to 2 (total score 0-8). A CPOT score ≥3 will be considered indicative of clinically significant pain.
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Anxiety scores
Lasso di tempo: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Anxiety/agitation level will be assessed using the Richmond Agitation-Sedation Scale (RASS). The RASS ranges from +4 (combative) to -5 (unarousable), with 0 indicating an alert and calm state. Positive scores reflect agitation and negative scores reflect increasing levels of sedation.
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
ICU length of stay
Lasso di tempo: From ICU admission until ICU discharge, assessed for up to one month.
The time between admission to the ICU and discharge from the ICU will be measured. This information will be derived from discharge documentation in Epic.
From ICU admission until ICU discharge, assessed for up to one month.
Incidence of new Grade 2 or higher pressure injury
Lasso di tempo: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Safety event defined as development of a new Grade 2 or higher pressure injury. Pressure injury will be measured using the Braden Scale and by visual skin inspection. Risk factors are divided into six categories and are rated on a scale of 1 to 4. These measures are added up, and the total score indicates a patient's risk level for developing a pressure injury. A range between 19-23 indicates no risk, 15-18 indicates mild risk, 13-14 is a moderate risk, 10-12 is a high risk, and any number less than 9 is a severe risk.
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Incidence of sustained elevated core temperature
Lasso di tempo: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Safety event defined as a core temperature greater than 100.4 degrees Fahrenheit (38 degrees Celsius) that persists of greater than or equal to 1 hour after blanket removal without alternative clinical explanation. Core temperature will be measured with standard Medical ICU temperature monitoring.
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Feasibility success
Lasso di tempo: From study initiation until the last participant completes study participation, assessed for up to 1 year.
Feasibility success will be defined as achievement of both prespecified feasibility criteria: (1) enrollment of ≥50% of eligible participants and (2) collection of complete outcome data for ≥80% of enrolled participants. The outcome will be reported as whether the study met both feasibility criteria.
From study initiation until the last participant completes study participation, assessed for up to 1 year.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Massachusetts General Hospital

Investigatori

  • Investigatore principale: Jennifer E. Cahill, PhD, RN, Massachusetts General Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 agosto 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2026P000726

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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