NCT03031379

Brief Summary

Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

April 20, 2018

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

January 22, 2017

Last Update Submit

April 18, 2018

Conditions

Intubated ICU Patients

Outcome Measures

Primary Outcomes (1)

  • Calories delivered

    Calories delivered before and after surgery

    72 hours

Secondary Outcomes (1)

  • Aspiration

    5 days

Study Arms (2)

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

Other: shortened fast

Interventions

shortened fastOTHER

fast of 45 minutes prior to surgery as opposed to standard 6 hour fast

B - shortened fast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent

You may not qualify if:

  • pregnant, \<18yo, cannot tolerate enteral feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2017

First Posted

January 25, 2017

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 20, 2018

Record last verified: 2012-02

Locations

US(1)