GastroparesisNCT03438305
Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.
An observational study of Gastroparesis, run by Cairo University.
Trial summary
Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- sonar assessment of gastric volume in Diabetic patients and sonar assessment of gastric volume in Non Diabetic patients
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Jun 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect gastric nerve supply.
Who may be able to join
- Ages from 40 to 60 years old.
- American Society of Anesthiologist (ASA) II.
- Diabetic patients with longstanding duration(more than 6 years).
Who cannot join
- Age <40,>60 years .
- Pregnant female
- Obese patients (BMI ≤40)
- Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.
- Diabetic patients less than 6 years.
About this study
Official title: Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).
Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume >1.5 ml/kg) during the preoperative period in longstanding diabetic patients.
Study population :
Read more
- -Longstanding diabetic patients (group D)
- -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.
Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups.
Second set of analysis will be finding correlation between US findings and suction volume in two groups.
Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients.
Sample Size ; was calculated as 48 patients (24) in each group.
- Conditions
- Gastroparesis
- Being tested
- sonar assessment of gastric volume in Diabetic patients, sonar assessment of gastric volume in Non Diabetic patients
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonar assessment of gastric volume in Diabetic patientsOther
assessment of gastric volume in Diabetic Patients
sonar assessment of gastric volume in Non Diabetic patientsOther
assessment of gastric volume in Non- Diabetic Patients
| Study group | Role | What they receive |
|---|---|---|
| Group D | Not described Receives: Other: sonar assessment of gastric volume in Diabetic patients | |
| Group N | Not described Receives: Other: sonar assessment of gastric volume in Non Diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of residual gastric volume in longstanding diabetic patients
To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients
Measured: intra-operative
Secondary outcomes (1)
correlation between preoperative gastric US findings and fasting hours in both groups
To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherin Refaat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438305
- Sponsor's protocol ID
- N-74-2017
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.
PubMed 30609007
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).
- ClinicalTrials.gov ID
- NCT03438305
- Acronym / sponsor ID
- N-74-2017
- Conditions
- Gastroparesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 19 Feb 2018 (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.
Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume >1.5 ml/kg) during the preoperative period in longstanding diabetic patients.
Study population :
- -Longstanding diabetic patients (group D)
- -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.
Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups.
Second set of analysis will be finding correlation between US findings and suction volume in two groups.
Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients.
Sample Size ; was calculated as 48 patients (24) in each group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | – | Other: sonar assessment of gastric volume in Diabetic patients |
| Group N | – | Other: sonar assessment of gastric volume in Non Diabetic patients |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect gastric nerve supply.
Key inclusion criteria (3 listed)
- Ages from 40 to 60 years old.
- American Society of Anesthiologist (ASA) II.
- Diabetic patients with longstanding duration(more than 6 years).
Key exclusion criteria (5 listed)
- Age <40,>60 years .
- Pregnant female
- Obese patients (BMI ≤40)
- Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.
- Diabetic patients less than 6 years.
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 |
|---|---|---|
| sonar assessment of gastric volume in Diabetic patientsassessment of gastric volume in Diabetic Patients | Other | Group D |
| sonar assessment of gastric volume in Non Diabetic patientsassessment of gastric volume in Non- Diabetic Patients | Other | Group N |
Primary outcome
assessment of residual gastric volume in longstanding diabetic patients
Time frame: intra-operative
To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients
1 secondary outcome
correlation between preoperative gastric US findings and fasting hours in both groups
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 30609007Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by Cairo University.
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 3 inclusion and 5 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
assessment of residual gastric volume in longstanding diabetic patients (time frame: intra-operative). 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 NCT03438305, which also lists 1 linked publication.
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 19 Feb 2018.