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Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

6 août 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

64

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Massachusetts General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Weighted blanket
The intervention group will receive the hospital-grade weighted blanket, to add on to usual care.
Dispositif: 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
Comparateur factice: Standard hospital linens
The control group will receive standard hospital bedding, which is part of usual care.
Dispositif: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sedation quality
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Acceptability of study
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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 sustained elevated core temperature
Délai: 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
Délai: 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.
Incidence of new Grade 2 or higher pressure injury on the anterior body surface
Délai: 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 on the anterior body surface. Pressure injuries will be classified using the National Pressure Injury Advisory Panel (NPIAP) staging system. Stage 1 is intact skin with non-blanchable erythema; Stage 2 is partial-thickness skin loss; Stage 3 is full-thickness skin loss extending into adipose tissue; Stage 4 is full-thickness skin and tissue loss with exposed deeper structures; Unstageable indicates depth obscured by slough/eschar; and Deep Tissue Pressure Injury is underlying soft tissue damage manifested as deep discoloration or a blood-filled blister.
Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Les enquêteurs

  • Chercheur principal: Jennifer E. Cahill, PhD, RN, Massachusetts General Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 août 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

2 juillet 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

17 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2026P000726

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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