Intubated ICU PatientsNCT03031379
Shortened Preoperative Fasts in ICU
A study testing shortened fast in people with Intubated ICU Patients, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubated ICU Patients
- What is being tested?
- shortened fast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2014
- 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
- intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent
Who cannot join
- pregnant, <18yo, cannot tolerate enteral feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy
Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.
Read the detailed description
Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.
- Conditions
- Intubated ICU Patients
- Being tested
- shortened fast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shortened fastOther
fast of 45 minutes prior to surgery as opposed to standard 6 hour fast
| Study group | Role | What they receive |
|---|---|---|
| A - control | No intervention | standard fast, at least 6 hours prior to tracheotomy |
| B - shortened fast | Experimental | fast of only 45 minutes prior to incision Receives: Other: shortened fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories delivered
Calories delivered before and after surgery
Measured: 72 hours
Secondary outcomes (1)
Aspiration
intraoperative or postoperative aspiration
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubated ICU PatientsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031379
- Sponsor's protocol ID
- MMC-12-06-219
- Status last verified
- Feb 2012
- First submitted
- 22 Jan 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy
- ClinicalTrials.gov ID
- NCT03031379
- Acronym / sponsor ID
- MMC-12-06-219
- Conditions
- Intubated ICU Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.
Detailed description
Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - control | No intervention | –standard fast, at least 6 hours prior to tracheotomy |
| B - shortened fast | Experimental | Other: shortened fastfast of only 45 minutes prior to incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent
Key exclusion criteria (1 listed)
- pregnant, <18yo, cannot tolerate enteral feeding
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 |
|---|---|---|
| shortened fastfast of 45 minutes prior to surgery as opposed to standard 6 hour fast | Other | B - shortened fast |
Primary outcome
Calories delivered
Time frame: 72 hours
Calories delivered before and after surgery
1 secondary outcome
Aspiration
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
Related trials for Intubated ICU Patients
Recruiting
Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
Intubated Patient Requiring a Gastric Tube
Recruiting
The Effects of Endotracheal Suctioning on Pain and Serum Markers
Intensive Care Unit ICU, Intubation
RecruitingObservational study
Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients
Intubated ICU Patients, Ventilator Associated Pneumonia ( VAP)
Not yet recruiting
Ventilator Study in the NICU
Neuro-intensive Care Unit Patients
RecruitingObservational study
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
Intensive Care
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 shortened fast in people with Intubated ICU Patients, run by Montefiore Medical Center 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Apr 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calories delivered (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2018.