UltrasonographyNCT04833530
The Effect of Preoperative Anxiety, on Gastric Antrum Size in Women Undergoing in Vitro Fertilization
An observational study of Ultrasonography, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Pulmonary aspiration is one of the most serious risks of general anesthesia and has been reported to occur in as many as 1 in 4000 cases of general anesthesia. Gastric ultrasound is an emerging point-of-care tool that provides bedside information on gastric content and volume. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Ultrasonography
- What is being tested?
- Gastric Ultrasound
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2021to 1 Dec 2022
- 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 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.
Who may be able to join
- Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.
Who cannot join
- Women with BMI >40
- Women with diabetes
- Women who have previously undergone gastric surgery
- Women with language barriers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Anxiety, Extent of Ovarian Stimulation, and Positive Pressure Ventilation on Gastric Antrum Size in Women Undergoing Oocyte Pickup for in Vitro Fertilization Under General Anaesthesia.
Pulmonary aspiration is one of the most serious risks of general anesthesia and has been reported to occur in as many as 1 in 4000 cases of general anesthesia. Gastric ultrasound is an emerging point-of-care tool that provides bedside information on gastric content and volume.
There have been a few factors which are thought to increase gastric size. Delayed gastric emptying such as caused by gastroparesis in Diabetes Mellitus is an example. Certain surgeries also cause gastroparesis. Other preoperative factors including pain, preoperative anxiety, and blood levels of estradiol or progesterone are less well studied.
Read the detailed description
Women will be recruited before undergoing the procedure.
Upon signed informed consent, women will be asked to rank their anxiety level on a scale of 0-10 (Verbal Numeric Anxiety Score). This scale has been used for previous studies to assess anxiety (Orbach-Zinger, Danon)
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. This study is purely observational, the gastric ultrasound assessment is non-invasive and will not cause any adverse effects or discomfort to the patient. Participation in the study will not affect clinical management in any way.
Each one of the ultrasound assessments will be performed by one of the study's' investigators.
Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
At the end of the procedure, the gastric ultrasound circumference will be measured again.
- Conditions
- Ultrasonography
- Being tested
- Gastric Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasoundDiagnostic test
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
At the end of the procedure, the gastric ultrasound circumference will be measured again.
| Study group | Role | What they receive |
|---|---|---|
| Woman undergoing an gastric ultrasound assessment. | Woman undergoing general anesthesia for oocyte retrieval during in vitro fertilization, will undergo an gastric ultrasound assessment. Receives: Diagnostic Test: Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative gastric ultrasound measurement
Measured: Within 24 hours before Oocyte pickup
Post-anesthesia gastric ultrasound measurement
Measured: During Oocyte pickup 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Dec 2022 (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 UltrasonographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Orbach-zinger, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833530
- Sponsor's protocol ID
- 0010-21
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Azem K, Orbach-Zinger S, Heesen P, Finkelstein A, Eidelman LA, Shufaro Y, Arzola C. The effect of preoperative anxiety and ovarian stimulation on gastric antrum size: a prospective observational study. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2170226. doi: 10.1080/0167482X.2023.2170226.
PubMed 36774546
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Anxiety, Extent of Ovarian Stimulation, and Positive Pressure Ventilation on Gastric Antrum Size in Women Undergoing Oocyte Pickup for in Vitro Fertilization Under General Anaesthesia.
- ClinicalTrials.gov ID
- NCT04833530
- Acronym / sponsor ID
- 0010-21
- Conditions
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 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.
Pulmonary aspiration is one of the most serious risks of general anesthesia and has been reported to occur in as many as 1 in 4000 cases of general anesthesia. Gastric ultrasound is an emerging point-of-care tool that provides bedside information on gastric content and volume.
There have been a few factors which are thought to increase gastric size. Delayed gastric emptying such as caused by gastroparesis in Diabetes Mellitus is an example. Certain surgeries also cause gastroparesis. Other preoperative factors including pain, preoperative anxiety, and blood levels of estradiol or progesterone are less well studied.
Detailed description
Women will be recruited before undergoing the procedure.
Upon signed informed consent, women will be asked to rank their anxiety level on a scale of 0-10 (Verbal Numeric Anxiety Score). This scale has been used for previous studies to assess anxiety (Orbach-Zinger, Danon)
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. This study is purely observational, the gastric ultrasound assessment is non-invasive and will not cause any adverse effects or discomfort to the patient. Participation in the study will not affect clinical management in any way.
Each one of the ultrasound assessments will be performed by one of the study's' investigators.
Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
At the end of the procedure, the gastric ultrasound circumference will be measured again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woman undergoing an gastric ultrasound assessment. | – | Diagnostic Test: Gastric UltrasoundWoman undergoing general anesthesia for oocyte retrieval during in vitro fertilization, will undergo an gastric ultrasound assessment. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.
Key inclusion criteria (1 listed)
- Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.
Key exclusion criteria (4 listed)
- Women with BMI >40
- Women with diabetes
- Women who have previously undergone gastric surgery
- Women with language barriers.
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 |
|---|---|---|
| Gastric UltrasoundIn the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital. At the end of the procedure, the gastric ultrasound circumference will be measured again. | Diagnostic test | Woman undergoing an gastric ultrasound assessment. |
Primary outcome
Preoperative gastric ultrasound measurement
Time frame: Within 24 hours before Oocyte pickup
Post-anesthesia gastric ultrasound measurement
Time frame: During Oocyte pickup 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 36774546Azem K, Orbach-Zinger S, Heesen P, Finkelstein A, Eidelman LA, Shufaro Y, Arzola C. The effect of preoperative anxiety and ovarian stimulation on gastric antrum size: a prospective observational study. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2170226. doi: 10.1080/0167482X.2023.2170226.
- Individual participant dataSharing planned: Undecided
Related trials for Ultrasonography
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Sharon Orbach-zinger principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, run by Rabin Medical Center 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 1 inclusion and 4 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 6 Apr 2021. 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?
Contact Sharon Orbach-Zinger (972 54-538-3093, sharonorbach@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative gastric ultrasound measurement (time frame: Within 24 hours before Oocyte pickup). 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 NCT04833530, 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 6 Apr 2021.