Mechanical VentilationNCT04825717
Calorimetry Guided Nutrition vs. Recommended Daily Intake in Weaning Chronically Ventilated Patients: Double Blind RCT.
A study testing Nutrition and fluid plans prepared using calorimetry-based measurements. in people with Mechanical Ventilation, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial summary
In this study, we intend to examine the effectiveness of an indirect calorimetry-guided nutrition plan, compared to the conventional, RDI-guided nutrition plan in mechanically ventilated patients, in terms of success rates of prolonged ventilation weaning, and shorter weaning time period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Nutrition and fluid plans prepared using calorimetry-based measurements.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Newly admitted prolonged mechanical ventilation patients on tracheostomy tube ventilation (over 21 days, a minimum of 6 hours a day);
- Over 18 years of age;
- PEEP below 8 cm H2O;
- FiO2 below 60%;
- Hemodynamically stable:
- Alert and oriented (does not apply to patients in a vegetative state);
Show all 11Show fewer
- Blood pressure at or above 80/50 mmHg;
- Body temperature - normal around 36.6°C;
- Heart rate - 40-140 beats per minute;
- Breath - 10-20 breaths per minute;
- No active infection (clinically stable patients receiving antibiotic treatment for more than 48 hours following an acute infection may be enrolled in the trial);
Who cannot join
- Ventilated patients with PEEP values exceeding 8 cmH2O, which mandates the use of FiO2 values over 60%;
- Hemodynamically unstable patients:
- Blood pressure below 80/50 mmHg;
- Over 140 beats per minute, or less than 40 beats per minute in symptomatic patients;
- Newly diagnosed fever (over 38.0°C);
- Patients receiving antibiotics for an active infection, under 48 hours.
- Blood pH values below 7.3 due to metabolic abnormality;
- Patients with irreversible advanced musculoskeletal neurodegenerative disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Examine the Efficacy of a Calorimetry Guided Nutritional Plan vs. the Recommended Daily Intake Guided Nutritional Plan in Weaning Chronically Ventilated Patients
In this study, we intend to examine the effectiveness of an indirect calorimetry-guided nutrition plan, compared to the conventional, RDI-guided nutrition plan in mechanically ventilated patients, in terms of success rates of prolonged ventilation weaning, and shorter weaning time period.
Hypotheses: The rates of chronically ventilated patients weaned off invasive ventilation will increase by 15% in the intervention group, and the average weaning period in this group will be reduced by 10 ± 4 days.
Methods: A randomized controlled intervention trial that will include 200 chronically ventilated patients, admitted to the "Reuth" Rehabilitation Hospital, who meet the criteria for weaning from prolonged mechanical ventilation. Patients in the intervention group (n=100) will undergo precise calorimetric measurements using indirect calorimetry and will be administered with a nutrition plan in accordance with these measurements. Nutrition plans of patients in the control group (n=100) will be calculated and administered according to current RDI conventions (up to 24 Kcal/kg/day). In order to assure blinding, patients in the control group will undergo the same calorimetric measurements using indirect calorimetry, however, these results will not be used in any way to determine or influence the nutritional plan.
Read the detailed description
Background: The number of patients in need of prolonged mechanical ventilation as means of life support is rapidly growing due to advancements in life-saving medical care for critically ill patients, an aging population, and the expanding use of aggressive surgical treatments. Both overfeeding and underfeeding are found to negatively affect the weaning process from mechanical ventilation. The caloric demands of chronically ventilated patients are reduced due to immobility and minimal energy requirements. Nowadays, nutrition plans are determined using the RDI (recommended dietary intake) formula, according to a patient's own weight and height. The RDI formula does not take into account the negligible activity levels of chronically ventilated patients or their deteriorating muscle mass, which is severely reduced due to prolonged periods of inactivity. This, in turn, may lead to increased body fat mass and fluid retention - which are both deleterious to the patients' health and may hinder their weaning from prolonged mechanical ventilation. Calorimetry is an accurate tool for measuring energy expenditures allowing us to assess the actual energy requirements of every patient. In indirect calorimetry, measurements of gas exchange are used to determine oxygen consumption versus the production and release of carbon dioxide. The "Reuth" Rehabilitation Hospital houses 108 chronically ventilated adult patients at a given moment, with turnover rates of 70-80 patients per year. If possible, these patients eventually undergo ventilation weaning. The current success rate for ventilation weaning reaches 55%, with a total duration of approximately two months.
Aim: To increase the success rates of prolonged ventilation weaning, i.e achieve a higher percentage of patients who successfully undergo mechanical ventilation weaning, with a shorter overall weaning time.
Hypotheses: The rates of chronically ventilated patients weaned off invasive ventilation will increase to 70% in the intervention group, and the average weaning period will be reduced by 10 ± 4 days.
Methods: A randomized controlled intervention trial that will include 200 chronically ventilated patients admitted to the "Reuth" Rehabilitation Hospital, who meet the criteria for weaning from prolonged mechanical ventilation. Patients in the intervention group (n=100) will undergo precise calorimetric measurements using indirect calorimetry and will be administered with a nutrition plan in accordance with these measurements. Nutrition plans of patients in the control group (n=100) will be calculated and administered according to current RDI conventions (up to 24 Kcal/kg/day). In order to assure blinding, patients in the control group will undergo the same calorimetric measurements using indirect calorimetry, however, these results will not be used in any way to determine or influence the nutritional plan.
Significance: In the United States, the use of prolonged mechanical ventilation increases by 5.5% annually, while total admissions rates increase by just 1% per year. According to estimates, the total number of patients requiring prolonged mechanical ventilation will be doubled by 2020, reaching 305,898 cases. It is safe to assume that similar trends exist in Israel, where 635 hospital beds are allocated to the ventilated patients. The total monthly admission costs for every ventilated patient in Israel are estimated at 14,140 USD, reaching nine million USD a year. Prolonged mechanical ventilation has a negative impact on both the patient and his family while caring for ventilated patients imposes a heavy burden on the health care system. In this study, we strive to increase the success rates of prolonged ventilation weaning, thereby improving ventilated patients' outcomes and alleviating the hardships inflicted on the patients, their families, and the health care system as a whole.
- Conditions
- Mechanical Ventilation
- Being tested
- Nutrition and fluid plans prepared using calorimetry-based measurements.
- Keywords
- Weaning, Mechanical Ventilation, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and fluid plans prepared using calorimetry-based measurements.Other
Nutrition and fluid plans prepared using calorimetry-based measurements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in this group will be administered nutrition and fluid plans prepared by the department dietitian using calorimetry-based measurements Receives: Other: Nutrition and fluid plans prepared using calorimetry-based measurements. |
| Control group | No intervention | Nutrition plans of patients in this group will be calculated by the department dietitian using the standard, currently accepted RDI (recommended dietary intake) formula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weaning
Rate of successful weaning, i.e. a number of patients successfully weaned from prolonged mechanical ventilation, out of those who underwent weaning attempts.
Measured: Within 8 weeks
Time to successful weaning
Time period in days from randomization to one of the studies groups and until successful weaning or 5 failed consecutive weaning attempts.
Measured: Within 8 weeks
Secondary outcomes (2)
Discharge destination following successful weaning
Discharge destination (other department, other hospital, home, nursing home)
Measured: Within 8 weeks
Three months survival rates post-weaning
Three months survival rates of patients who underwent successful weaning from mechanical ventilation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Dec 2019
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- 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
- Model description
- A randomized controlled double-blinded clinical trial. Intervention group: patients in this group will be administered nutrition and fluid plans prepared by the department dietitian using calorimetry-based measurements. Control group: The nutrition plans of patients in this group will be calculated by the department dietitian using the standard, currently accepted RDI (recommended dietary intake) formula. Nutrition will be administered according to these calculations. All patients included in this trial will receive a multivitamin supplement to prevent possible vitamin deficiencies.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825717
- Sponsor's protocol ID
- 0014-18-RRH
- Status last verified
- Jul 2023
- First submitted
- 15 Mar 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fradkin M, Elyashiv M, Brik M, Agay N, Kait MG, Bornstein L, Margalit T, Singer P, Dankner R. Indirect calorimetry-guided nutrition during weaning from prolonged mechanical ventilation: a double-blind randomized controlled trial. Crit Care. 2026 Aug 28;30(1):496. doi: 10.1186/s13054-026-06272-7.
PubMed 42791574Fradkin M, Elyashiv M, Brik M, Kait MG, Albukrek D, Singer P, Dankner R. The efficacy of calorimetry-based nutritional support versus recommended dietary intake-based nutritional support in the successful weaning of chronically ventilated patients: A study protocol for a double blind randomized controlled trial. Clin Nutr ESPEN. 2023 Apr;54:94-97. doi: 10.1016/j.clnesp.2023.01.003. Epub 2023 Jan 13.
PubMed 36963903
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Examine the Efficacy of a Calorimetry Guided Nutritional Plan vs. the Recommended Daily Intake Guided Nutritional Plan in Weaning Chronically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04825717
- Acronym / sponsor ID
- 0014-18-RRH
- Conditions
- Mechanical Ventilation
- Keywords
- Weaning, Mechanical Ventilation, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Apr 2021 (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.
In this study, we intend to examine the effectiveness of an indirect calorimetry-guided nutrition plan, compared to the conventional, RDI-guided nutrition plan in mechanically ventilated patients, in terms of success rates of prolonged ventilation weaning, and shorter weaning time period.
Hypotheses: The rates of chronically ventilated patients weaned off invasive ventilation will increase by 15% in the intervention group, and the average weaning period in this group will be reduced by 10 ± 4 days.
Methods: A randomized controlled intervention trial that will include 200 chronically ventilated patients, admitted to the "Reuth" Rehabilitation Hospital, who meet the criteria for weaning from prolonged mechanical ventilation. Patients in the intervention group (n=100) will undergo precise calorimetric measurements using indirect calorimetry and will be administered with a nutrition plan in accordance with these measurements. Nutrition plans of patients in the control group (n=100) will be calculated and administered according to current RDI conventions (up to 24 Kcal/kg/day). In order to assure blinding, patients in the control group will undergo the same calorimetric measurements using indirect calorimetry, however, these results will not be used in any way to determine or influence the nutritional plan.
Detailed description
Background: The number of patients in need of prolonged mechanical ventilation as means of life support is rapidly growing due to advancements in life-saving medical care for critically ill patients, an aging population, and the expanding use of aggressive surgical treatments. Both overfeeding and underfeeding are found to negatively affect the weaning process from mechanical ventilation. The caloric demands of chronically ventilated patients are reduced due to immobility and minimal energy requirements. Nowadays, nutrition plans are determined using the RDI (recommended dietary intake) formula, according to a patient's own weight and height. The RDI formula does not take into account the negligible activity levels of chronically ventilated patients or their deteriorating muscle mass, which is severely reduced due to prolonged periods of inactivity. This, in turn, may lead to increased body fat mass and fluid retention - which are both deleterious to the patients' health and may hinder their weaning from prolonged mechanical ventilation. Calorimetry is an accurate tool for measuring energy expenditures allowing us to assess the actual energy requirements of every patient. In indirect calorimetry, measurements of gas exchange are used to determine oxygen consumption versus the production and release of carbon dioxide. The "Reuth" Rehabilitation Hospital houses 108 chronically ventilated adult patients at a given moment, with turnover rates of 70-80 patients per year. If possible, these patients eventually undergo ventilation weaning. The current success rate for ventilation weaning reaches 55%, with a total duration of approximately two months.
Aim: To increase the success rates of prolonged ventilation weaning, i.e achieve a higher percentage of patients who successfully undergo mechanical ventilation weaning, with a shorter overall weaning time.
Hypotheses: The rates of chronically ventilated patients weaned off invasive ventilation will increase to 70% in the intervention group, and the average weaning period will be reduced by 10 ± 4 days.
Methods: A randomized controlled intervention trial that will include 200 chronically ventilated patients admitted to the "Reuth" Rehabilitation Hospital, who meet the criteria for weaning from prolonged mechanical ventilation. Patients in the intervention group (n=100) will undergo precise calorimetric measurements using indirect calorimetry and will be administered with a nutrition plan in accordance with these measurements. Nutrition plans of patients in the control group (n=100) will be calculated and administered according to current RDI conventions (up to 24 Kcal/kg/day). In order to assure blinding, patients in the control group will undergo the same calorimetric measurements using indirect calorimetry, however, these results will not be used in any way to determine or influence the nutritional plan.
Significance: In the United States, the use of prolonged mechanical ventilation increases by 5.5% annually, while total admissions rates increase by just 1% per year. According to estimates, the total number of patients requiring prolonged mechanical ventilation will be doubled by 2020, reaching 305,898 cases. It is safe to assume that similar trends exist in Israel, where 635 hospital beds are allocated to the ventilated patients. The total monthly admission costs for every ventilated patient in Israel are estimated at 14,140 USD, reaching nine million USD a year. Prolonged mechanical ventilation has a negative impact on both the patient and his family while caring for ventilated patients imposes a heavy burden on the health care system. In this study, we strive to increase the success rates of prolonged ventilation weaning, thereby improving ventilated patients' outcomes and alleviating the hardships inflicted on the patients, their families, and the health care system as a whole.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized controlled double-blinded clinical trial. Intervention group: patients in this group will be administered nutrition and fluid plans prepared by the department dietitian using calorimetry-based measurements. Control group: The nutrition plans of patients in this group will be calculated by the department dietitian using the standard, currently accepted RDI (recommended dietary intake) formula. Nutrition will be administered according to these calculations. All patients included in this trial will receive a multivitamin supplement to prevent possible vitamin deficiencies.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Nutrition and fluid plans prepared using calorimetry-based measurements.Patients in this group will be administered nutrition and fluid plans prepared by the department dietitian using calorimetry-based measurements |
| Control group | No intervention | –Nutrition plans of patients in this group will be calculated by the department dietitian using the standard, currently accepted RDI (recommended dietary intake) formula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Newly admitted prolonged mechanical ventilation patients on tracheostomy tube ventilation (over 21 days, a minimum of 6 hours a day);
- Over 18 years of age;
- PEEP below 8 cm H2O;
- FiO2 below 60%;
- Hemodynamically stable:
Key exclusion criteria (8 listed)
- Ventilated patients with PEEP values exceeding 8 cmH2O, which mandates the use of FiO2 values over 60%;
- Hemodynamically unstable patients:
- Patients receiving antibiotics for an active infection, under 48 hours.
- Blood pH values below 7.3 due to metabolic abnormality;
- Patients with irreversible advanced musculoskeletal neurodegenerative disorders.
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 |
|---|---|---|
| Nutrition and fluid plans prepared using calorimetry-based measurements.Nutrition and fluid plans prepared using calorimetry-based measurements. | Other | Intervention group |
Primary outcome
Successful weaning
Time frame: Within 8 weeks
Rate of successful weaning, i.e. a number of patients successfully weaned from prolonged mechanical ventilation, out of those who underwent weaning attempts.
Time to successful weaning
Time frame: Within 8 weeks
Time period in days from randomization to one of the studies groups and until successful weaning or 5 failed consecutive weaning attempts.
2 secondary outcomes
Discharge destination following successful weaning
Time frame: Within 8 weeks
Three months survival rates post-weaning
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 42791574Fradkin M, Elyashiv M, Brik M, Agay N, Kait MG, Bornstein L, Margalit T, Singer P, Dankner R. Indirect calorimetry-guided nutrition during weaning from prolonged mechanical ventilation: a double-blind randomized controlled trial. Crit Care. 2026 Aug 28;30(1):496. doi: 10.1186/s13054-026-06272-7.
- Derived from this study: PubMed 36963903Fradkin M, Elyashiv M, Brik M, Kait MG, Albukrek D, Singer P, Dankner R. The efficacy of calorimetry-based nutritional support versus recommended dietary intake-based nutritional support in the successful weaning of chronically ventilated patients: A study protocol for a double blind randomized controlled trial. Clin Nutr ESPEN. 2023 Apr;54:94-97. doi: 10.1016/j.clnesp.2023.01.003. Epub 2023 Jan 13.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and fluid plans prepared using calorimetry-based measurements. in people with Mechanical Ventilation, run by Reuth Rehabilitation Hospital at 1 site in Israel.
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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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 Israel. 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. 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?
Results are not available in the source record.
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?
Successful weaning (time frame: Within 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04825717, which also lists 2 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 11 Jul 2023.