Ventilated Patient in Intensive CareNCT07710469
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
A study testing Weighted blanket and Standard hospital linens in people with Ventilated Patient in Intensive Care, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patient in Intensive Care
- What is being tested?
- Weighted blanket and Standard hospital linens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Concurrent enrollment in another interventional trial affecting sedation or ventilation
- Anticipated withdrawal of life-sustaining therapy
- Pregnant individuals in the 2nd or 3rd trimester•
- Patients under Contact Plus Isolation Precautions or Strict Isolation Precautions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Ventilated Patient in Intensive Care
- Being tested
- Weighted blanket, Standard hospital linens
- Keywords
- Weighted blankets, Mechanical ventilation, Nursing care, Nonpharmacologic interventions, Intensive care units, Sedation reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted blanketDevice
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
Standard hospital linensDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Weighted blanket | Experimental | The intervention group will receive the hospital-grade weighted blanket, to add on to usual care. Receives: Device: Weighted blanket |
| Standard hospital linens | Sham comparator | The control group will receive standard hospital bedding, which is part of usual care. Receives: Device: Standard hospital linens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation quality
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.
Measured: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Secondary outcomes (10)
Acceptability of study
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.
Measured: From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Sedative and analgesic exposure
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).
Measured: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Time to extubation
The time between ventilator weaning and extubation will be derived from Epic nursing flowsheets.
Measured: From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Delirium incidence
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.
Measured: Daily from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Pain severity
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.
Measured: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Anxiety scores
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.
Measured: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
ICU length of stay
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.
Measured: From ICU admission until ICU discharge, assessed for up to one month.
Incidence of new Grade 2 or higher pressure injury on the anterior body surface
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.
Measured: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Incidence of sustained elevated core temperature
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.
Measured: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Feasibility success
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.
Measured: From study initiation until the last participant completes study participation, assessed for up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start17 Aug 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilated Patient in Intensive CareStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Cahill, Massachusetts General Hospital
- Investigators
- Jennifer E. Cahill, PhD, RN, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710469
- Sponsor's protocol ID
- 2026P000726
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mullen B, Champagne T, Krishnamurty S, Dickson D, Gao RX. Exploring the safety and therapeutic effects of deep pressure stimulation using a weighted blanket. Am J Occup Ther. 2008;62(1):65-72.
Eron K, Kohnert L, Watters A, Logan C, Weisner-Rose M, Mehler PS. Weighted Blanket Use: A Systematic Review. Am J Occup Ther. 2020 Mar/Apr;74(2):7402205010p1-7402205010p14. doi: 10.5014/ajot.2020.037358.
PubMed 32204779Olsen HT, Nedergaard HK, Strom T, Oxlund J, Wian KA, Ytrebo LM, Kroken BA, Chew M, Korkmaz S, Lauridsen JT, Toft P. Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients. N Engl J Med. 2020 Mar 19;382(12):1103-1111. doi: 10.1056/NEJMoa1906759. Epub 2020 Feb 16.
PubMed 32068366Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Hospital-Grade Weighted Blanket to Improve Sedation Quality During Ventilator Weaning in the Blake 7 MICU (MGH)
- ClinicalTrials.gov ID
- NCT07710469
- Acronym / sponsor ID
- 2026P000726
- Conditions
- Ventilated Patient in Intensive Care
- Keywords
- Weighted blankets, Mechanical ventilation, Nursing care, Nonpharmacologic interventions, Intensive care units, Sedation reduction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted blanket | Experimental | Device: Weighted blanketThe intervention group will receive the hospital-grade weighted blanket, to add on to usual care. |
| Standard hospital linens | Sham comparator | Device: Standard hospital linensThe control group will receive standard hospital bedding, which is part of usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted blanketFor 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 | Device | Weighted blanket |
| Standard hospital linensFor 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 | Device | Standard hospital linens |
Primary outcome
Sedation quality
Time frame: 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.
10 secondary outcomes
Acceptability of study
Time frame: From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Sedative and analgesic exposure
Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Time to extubation
Time frame: From initiation of ventilator weaning until extubation, assessed for up to two weeks.
Delirium incidence
Time frame: Daily from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Pain severity
Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Anxiety scores
Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
ICU length of stay
Time frame: From ICU admission until ICU discharge, assessed for up to one month.
Incidence of new Grade 2 or higher pressure injury on the anterior body surface
Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Incidence of sustained elevated core temperature
Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.
Feasibility success
Time frame: From study initiation until the last participant completes study participation, assessed for up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- BackgroundMullen B, Champagne T, Krishnamurty S, Dickson D, Gao RX. Exploring the safety and therapeutic effects of deep pressure stimulation using a weighted blanket. Am J Occup Ther. 2008;62(1):65-72.
- Background: PubMed 32204779Eron K, Kohnert L, Watters A, Logan C, Weisner-Rose M, Mehler PS. Weighted Blanket Use: A Systematic Review. Am J Occup Ther. 2020 Mar/Apr;74(2):7402205010p1-7402205010p14. doi: 10.5014/ajot.2020.037358.
- Background: PubMed 32068366Olsen HT, Nedergaard HK, Strom T, Oxlund J, Wian KA, Ytrebo LM, Kroken BA, Chew M, Korkmaz S, Lauridsen JT, Toft P. Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients. N Engl J Med. 2020 Mar 19;382(12):1103-1111. doi: 10.1056/NEJMoa1906759. Epub 2020 Feb 16.
- Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer E. Cahill, PhD, RN principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted blanket and Standard hospital linens in people with Ventilated Patient in Intensive Care, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation quality (time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07710469, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.