Critical IllnessNCT02169193
Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
A study testing 99mTc-Rhenium Sulfide Nanocolloid in people with Critical Illness, run by University Hospital, Lille at 1 site in France.
Trial summary
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- 99mTc-Rhenium Sulfide Nanocolloid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jan 2017
- 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
- age > or = 18 years
- hospitalised in ICU
- tracheal intubation using a polyvinyl chloride tube and mechanical ventilation
- predictable mechanical ventilation > or = 6 hours after inclusion
- enteral nutrition by a nasogastric tube
Who cannot join
- refuse to participate to the study
- no informed consent
- pregnant
- contra-indication for enteral nutrition
- tracheotomy
- intubation or re-intubation done in 6 hours preceding the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.
Read the detailed description
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. We hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard
- Conditions
- Critical Illness
- Being tested
- 99mTc-Rhenium Sulfide Nanocolloid
- Keywords
- microaspiration, mechanical ventilation, enteral feeding, 99m technetium, pepsin
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-Rhenium Sulfide NanocolloidRadiation
Also called NanoCis
12 MBq of NanoCis added to 500 ml of enteral feeding
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-Rhenium Sulfide Nanocolloid | Experimental | 99mTc-Rhenium Sulfide Nanocolloid Receives: Radiation: 99mTc-Rhenium Sulfide Nanocolloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pepsin levels ≥200 ng / ml
Sensibility and sensitivity of Pepsin for the diagnosis of microaspiration will be determined with regard to 99m technetium (gold standard).
Measured: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Secondary outcomes (4)
likelihood ratio of pepsin of microregurgitation
Sensibility and sensitivity of Pepsin for the diagnosis of microregurgitation will be determined with regard to 99m technetium.
Measured: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
likelihood ratio of pepsin of microaspiration
positive and negative predictive values, positive and negative likelihood ratio of pepsin for the diagnosis of microaspiration compared to the 99m technetium (gold standard)
Measured: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Youden Index
Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)
Measured: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
ROC curve
Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)
Measured: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD, PhD, Principal investigator, Univ Hosp of Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169193
- Sponsor's protocol ID
- 2011_09
- Other IDs
- 2011-A0140932
- Status last verified
- Dec 2015
- First submitted
- 18 Jun 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
- ClinicalTrials.gov ID
- NCT02169193
- Acronym / sponsor ID
- 2011_09
- Conditions
- Critical Illness
- Keywords
- microaspiration, mechanical ventilation, enteral feeding, 99m technetium, pepsin
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 23 Jun 2014 (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.
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.
Detailed description
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. We hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-Rhenium Sulfide Nanocolloid | Experimental | Radiation: 99mTc-Rhenium Sulfide Nanocolloid99mTc-Rhenium Sulfide Nanocolloid |
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 > or = 18 years
- hospitalised in ICU
- tracheal intubation using a polyvinyl chloride tube and mechanical ventilation
- predictable mechanical ventilation > or = 6 hours after inclusion
- enteral nutrition by a nasogastric tube
Key exclusion criteria (6 listed)
- refuse to participate to the study
- no informed consent
- pregnant
- contra-indication for enteral nutrition
- tracheotomy
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 |
|---|---|---|
| 99mTc-Rhenium Sulfide NanocolloidAlso: NanoCis12 MBq of NanoCis added to 500 ml of enteral feeding | Radiation | 99mTc-Rhenium Sulfide Nanocolloid |
Primary outcome
incidence of pepsin levels ≥200 ng / ml
Time frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Sensibility and sensitivity of Pepsin for the diagnosis of microaspiration will be determined with regard to 99m technetium (gold standard).
4 secondary outcomes
likelihood ratio of pepsin of microregurgitation
Time frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
likelihood ratio of pepsin of microaspiration
Time frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Youden Index
Time frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
ROC curve
Time frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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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.
Saad Nseir, MD, PhD principal investigator
Univ Hosp of Lille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-Rhenium Sulfide Nanocolloid in people with Critical Illness, run by University Hospital, Lille at 1 site in France.
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 6 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: withdrawn, as of the sponsor's last update on 4 Dec 2015. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
incidence of pepsin levels ≥200 ng / ml (time frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding). 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 4 Dec 2015.