Tidel Volume Challenge TestNCT05301582
T.V Challenge to Predict Early Post- Operative Acute Kidney Injury and Intra-operative Hypotension in Laparoscopic Abdominal Surgeries
An observational study of Tidel Volume Challenge Test, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of study is to verify the predictability of TV Chalange test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension. . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tidel Volume Challenge Test
- What is being tested?
- Tidal volume challenge test
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 18 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted in Kasr Alainy Hospital of Cairo University.
Who may be able to join
- Gender both males and females
- ASA Class I and II
- Age 18-65 years
- Patients undergoing elective laparoscopic surgery under general anaesthesia
Who cannot join
- Kidney dysfunction
- Cardiac arrhythmias and valvular heart disease
- Chronic obstructive pulmonary disease
- Right ventricular failure
- Intracranial hypertension
- Airway asthma or a long history of smoking
- Those who are on NSAID for 1 week prior to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ability of Tidal Volume Challenge Test to Predict Early Post- Operative Acute Kidney Injury and Intra-operative Hypotension in Laparoscopic Abdominal Surgeries. Prospective Observational Study.
The purpose of study is to verify the predictability of TV Chalange test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.
.
Read the detailed description
The number and scope of laparoscopic surgery are increasing. Now almost every abdominal organ seems suitable for laparoscopic surgery. Laparoscopy may be considered potentially risky because it may involve extreme changes in the patient's position, prolonged intra-abdominal insufflation and carbon dioxide (CO2) degassing, unexpected visceral damage, and difficulty in assessing blood loss. The anesthesiologist must select the appropriate anesthesia management technique, conduct proper monitoring, and be aware of potential complications. Early detection and reduction of possible intra-operative problems can prevent postoperative complications and early complications.
Laparoscopic injection of CO2 or N2O can cause cardiovascular depression . Insufflation at a high flow rate can also exacerbate cardiovascular sequelae, including hypotension and bradycardia, and cause cardiac arrest . Intra-operative hypotension caused by rapid laparoscopic inflation is caused by the vagal-mediated cardiovascular reflex caused by the rapid expansion of the peritoneum. It can also be attributed to the reduction in preload and venous return associated with the pneumo-peritoneum (PP) .
During the period of elevated intra-abdominal pressure, there are three different mechanisms of renal insufficiency, including hypercapnia caused by CO2 insufflation, elevated intra-abdominal pressure and renin-angiotensin-aldosterone system (RAAS) .
In another study, the incidence of AKI after laparoscopic abdominal surgery was 35.9%, which was higher than the previous study .
Patients with low-volume status are susceptible to AKI due to ischemic acute tubular necrosis due to renal insufficiency, and predisposed by hypotension as a pre-renal cause.
Although low volume status has a major role in post-operative AKI .Yet, there are rising theories explaining the increased incidence of AKI in patients undergoing laparoscopic surgeries to increased renal resistive index (RRI) by increased intra-abdominal pressure Intra-operative volume status indicators are variable, including inferior vena cava (IVC), carotid artery ratio (JCR), stroke volume change (SVV) and pulse pressure change (PPV). These indicators may be reliable, but complex, time-consuming, and require trained personnel and high-tech equipment .
The Tidal Volume Challenge (TVC) test is a new tool which is used to assess the volume status and it has been approved as a reliable tool in neurosurgery patients . However, as far as we know, it has not been used to predict hypotension and AKI in laparoscopic surgeries. We hypothesis that mimicking the effect of increased intra-abdominal pressure transiently for a short period of time by TVC test could contribute in detecting patients at high risk of developing post-operative AKI.
TVC test/ abdominal insufflation adverse consequences can be also explained mainly by reduced venous compliance in some patients leading to mobilization of blood to peripheral venous system, with reduced venous elasticity the passive blood recoil to the heart maintaining hemo-dynamic stability and organ perfusion will be diminished, aggravating the effect of increased intra-abdominal or intra-thoracic pressure. That mechanism has been studied in orthostatic hypotension The purpose of study is to verify the predictability of TVC test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.
.
- Conditions
- Tidel Volume Challenge Test
- Being tested
- Tidal volume challenge test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume challenge testDiagnostic test
The purpose of our study is to verify the predictability of TVC test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Group | A total of 70 consecutive adult patients, aged 18-65 years scheduled for elective laparoscopic surgery under general anesthesia will be included in the study. Receives: Diagnostic Test: Tidal volume challenge test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.
The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.
Measured: Through Study Completionan average of 24 hours
Secondary outcomes (4)
The sensitivity of TVC test to predict intraoperative post insufflation and desufflation hypotension.
The sensitivity of TVC test to predict intraoperative post insufflation and desufflation hypotension.
Measured: Through Study Completionan average of 24 hours
The relationship between exposure index (the product of inflation time x intra-abdominal pressure) and early post-operative AKI.
The relationship between exposure index (the product of inflation time x intra-abdominal
Measured: Through Study Completionan average of 24 hours
The incidence of AKI in laparoscopic surgeries.
The incidence of AKI in laparoscopic surgeries.
Measured: Through Study Completionan average of 24 hours
The ability of (uNGAL) to predict early post operative AKI.
The ability of (uNGAL) to predict early post operative AKI.
Measured: Through Study Completionan average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jan 2022
- Primary completion16 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tidel Volume Challenge TestStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Hala Mostafa Gomaa, Ahmed Mohamed Ahmed Mostafa, Mohamed Abdel Ghany Ali Elshazly
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed A Mohamed, M.D, Principal investigator, Cairo UniversityHala M Gomaa, M.D, Principal investigator, Cairo UniversityMohamed A Ali Elshazly, M.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301582
- Sponsor's protocol ID
- M.D- 302-2021
- Status last verified
- Jul 2022
- First submitted
- 12 Feb 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Tidal Volume Challenge Test to Predict Early Post- Operative Acute Kidney Injury and Intra-operative Hypotension in Laparoscopic Abdominal Surgeries. Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05301582
- Acronym / sponsor ID
- M.D- 302-2021
- Conditions
- Tidel Volume Challenge Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Hala Mostafa Gomaa, Ahmed Mohamed Ahmed Mostafa, Mohamed Abdel Ghany Ali Elshazly
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 29 Mar 2022 (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.
The purpose of study is to verify the predictability of TV Chalange test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.
.
Detailed description
The number and scope of laparoscopic surgery are increasing. Now almost every abdominal organ seems suitable for laparoscopic surgery. Laparoscopy may be considered potentially risky because it may involve extreme changes in the patient's position, prolonged intra-abdominal insufflation and carbon dioxide (CO2) degassing, unexpected visceral damage, and difficulty in assessing blood loss. The anesthesiologist must select the appropriate anesthesia management technique, conduct proper monitoring, and be aware of potential complications. Early detection and reduction of possible intra-operative problems can prevent postoperative complications and early complications.
Laparoscopic injection of CO2 or N2O can cause cardiovascular depression . Insufflation at a high flow rate can also exacerbate cardiovascular sequelae, including hypotension and bradycardia, and cause cardiac arrest . Intra-operative hypotension caused by rapid laparoscopic inflation is caused by the vagal-mediated cardiovascular reflex caused by the rapid expansion of the peritoneum. It can also be attributed to the reduction in preload and venous return associated with the pneumo-peritoneum (PP) .
During the period of elevated intra-abdominal pressure, there are three different mechanisms of renal insufficiency, including hypercapnia caused by CO2 insufflation, elevated intra-abdominal pressure and renin-angiotensin-aldosterone system (RAAS) .
In another study, the incidence of AKI after laparoscopic abdominal surgery was 35.9%, which was higher than the previous study .
Patients with low-volume status are susceptible to AKI due to ischemic acute tubular necrosis due to renal insufficiency, and predisposed by hypotension as a pre-renal cause.
Although low volume status has a major role in post-operative AKI .Yet, there are rising theories explaining the increased incidence of AKI in patients undergoing laparoscopic surgeries to increased renal resistive index (RRI) by increased intra-abdominal pressure Intra-operative volume status indicators are variable, including inferior vena cava (IVC), carotid artery ratio (JCR), stroke volume change (SVV) and pulse pressure change (PPV). These indicators may be reliable, but complex, time-consuming, and require trained personnel and high-tech equipment .
The Tidal Volume Challenge (TVC) test is a new tool which is used to assess the volume status and it has been approved as a reliable tool in neurosurgery patients . However, as far as we know, it has not been used to predict hypotension and AKI in laparoscopic surgeries. We hypothesis that mimicking the effect of increased intra-abdominal pressure transiently for a short period of time by TVC test could contribute in detecting patients at high risk of developing post-operative AKI.
TVC test/ abdominal insufflation adverse consequences can be also explained mainly by reduced venous compliance in some patients leading to mobilization of blood to peripheral venous system, with reduced venous elasticity the passive blood recoil to the heart maintaining hemo-dynamic stability and organ perfusion will be diminished, aggravating the effect of increased intra-abdominal or intra-thoracic pressure. That mechanism has been studied in orthostatic hypotension The purpose of study is to verify the predictability of TVC test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Diagnostic Test: Tidal volume challenge testA total of 70 consecutive adult patients, aged 18-65 years scheduled for elective laparoscopic surgery under general anesthesia will be included in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in Kasr Alainy Hospital of Cairo University.
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA Class I and II
- Age 18-65 years
- Patients undergoing elective laparoscopic surgery under general anaesthesia
Key exclusion criteria (7 listed)
- Kidney dysfunction
- Cardiac arrhythmias and valvular heart disease
- Chronic obstructive pulmonary disease
- Right ventricular failure
- Intracranial hypertension
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 |
|---|---|---|
| Tidal volume challenge testThe purpose of our study is to verify the predictability of TVC test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension. | Diagnostic test | Group |
Primary outcome
The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.
Time frame: Through Study Completionan average of 24 hours
The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.
4 secondary outcomes
The sensitivity of TVC test to predict intraoperative post insufflation and desufflation hypotension.
Time frame: Through Study Completionan average of 24 hours
The relationship between exposure index (the product of inflation time x intra-abdominal pressure) and early post-operative AKI.
Time frame: Through Study Completionan average of 24 hours
The incidence of AKI in laparoscopic surgeries.
Time frame: Through Study Completionan average of 24 hours
The ability of (uNGAL) to predict early post operative AKI.
Time frame: Through Study Completionan average of 24 hours
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 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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.
Ahmed A Mohamed, M.D principal investigator
Cairo University
Hala M Gomaa, M.D principal investigator
Cairo University
Mohamed A Ali Elshazly, M.D study director
Cairo University
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 Tidel Volume Challenge Test, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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 19 Jul 2022. 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 Egypt. 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?
The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries. (time frame: Through Study Completionan average of 24 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 19 Jul 2022.