Postoperative ComplicationsNCT07041021
Intraoperative Fluid Management Guided by Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries
A study testing Respiratory variation of the Internal Jugular Vein (IJV) in people with Postoperative Complications, run by Suez Canal University at 2 sites in Egypt.
Trial summary
This study investigates the role of respiratory variation in the internal jugular vein as a tool for intraoperative fluid management during abdominal surgeries under general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Respiratory variation of the Internal Jugular Vein (IJV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jul 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' American Society of Anesthesiologists physical status (ASA) is I and II.
- The target age group is 20 to 70 years old.
- Patients scheduled for abdominal surgery under general anesthesia with normal renal function.
Who cannot join
- Refusal of the procedure or participation in the study.
- Coagulopathy.
- Pre-existing cardiac, renal, and respiratory diseases. 4-Internal jugular vein thrombosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Suez Canal University Hospitals
Ismailia, Ismailia Governorate, 41522
Mohammad E Salama, MD, 00201016865861, MohammadElhossieny88@med.suez.edu.eg
- Recruiting
Suez Canal University Hospitals
Ismailia
Mohammad E Salama, MD, +201016865861, MohammadElhossieny88@med.suez.edu.eg
About this study
Official title: Effect of Intraoperative Fluid Management Guided by Respiratory Variations of Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries: A Prospective Randomized Controlled Trial
This study investigates the role of respiratory variation in the internal jugular vein as a tool for intraoperative fluid management during abdominal surgeries under general anesthesia.
The purpose of this clinical trial is to reduce postoperative complications and improve patient outcomes through proper intraoperative fluid management.
Read more
The main question it aims to answer is: Can intraoperative fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries reduce postoperative complications? Research Hypothesis (Alternative Hypothesis): We hypothesize that fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries can reduce postoperative complications.
The patients will be divided into two groups and randomized to receive either intraoperative fluid therapy guided by the respiratory variation of the internal jugular vein or standard fluid therapy. Postoperative complications, length of hospital stay, total amount of fluid administered intraoperatively, use of vasopressors in both groups, and incidence of hypotensive episodes will be recorded.
Read the detailed description
Sonographic measurement of respiratory variation of IJV will be performed with a Philips CX50 ultrasound device (Philips Healthcare, Hamburg, Germany), equipped with a linear transducer. Respiratory variation of IJV will be measured by the same anesthesiologist with sufficient experience in ultrasound guided IJV cannulation. The anesthesiologist performing the ultrasound examinations will not be involved in this study and blinded to the hemodynamic parameters; a lead plate separated the monitor from the anesthesiologist and ultrasound device. The optimal short axis of the IJV will be obtained at the level of the cricoid cartilage by placement of the transducer perpendicular to the skin on the patient's neck in a transverse plane. The vein will be identified with color Doppler imaging as well as by compression. Ultrasound measurements will be performed on the left IJV, M-mode scan will be used to record the IJV diameter at the end of inspiration (IJVmax) and expiration (IJVmin) over an entire respiratory cycle. The images will be then frozen. The respiratory variation of IJV will be calculated with the following formula: IJV RV (%) = (IJVmax - IJVmin)/ (IJVmin) × 100%. The average values of IJVmax and IJVmin from three consecutive respiratory circles will be used in the analysis.
The finding of a small-diameter IJV (<1cm) and increased IJV RV (>18) suggest low-volume states. Conversely, a large IJV diameter (>2.1cm) and decreased IJV RV (<18) will suggest a high-volume state.
- Conditions
- Postoperative Complications
- Being tested
- Respiratory variation of the Internal Jugular Vein (IJV)
- Keywords
- Postoperative Complications, Abdominal surgeries, Internal Jugular Vein, Intraoperative fluid therapy
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory variation of the Internal Jugular Vein (IJV)Diagnostic test
In the study group, the fluid therapy will be guided by the respiratory variation (RV) of the Internal Jugular Vein (IJV) throughout surgery. Fluid maintenance will be continued as long as the IJV diameter is less than 2 cm and the IJV RV is more than 18. If the IJV diameter exceeds 2 cm and the IJV RV is less than 18, fluids will be stopped.
| Study group | Role | What they receive |
|---|---|---|
| Internal Jugular Vein (IJV) group (Study group) | Active comparator | In this group, fluid therapy will be guided by the respiratory variation of IJV throughout the surgery. Receives: Diagnostic Test: Respiratory variation of the Internal Jugular Vein (IJV) |
| Control group | No intervention | In this group, conventional fluid therapy will be given to ensure that the mean arterial blood pressure is equal to or more than 65 mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the incidence of postoperative complications in both groups, which will be measured by the occurrence of any of the postoperative complications during the first seven postoperative days in both groups
Postoperative complications will include:
(i) infections (urinary tract infection, wound infection, sepsis/septic shock) (ii) GI (Ileus, acute bowel obstruction, GI bleeding, abdominal compartment syndrome), (iii) Cardiovascular (deep venous thrombosis, pulmonary embolism, myocardial ischemia or infarction, cardiac arrest), (iv) Renal (AKI) (v) Respiratory (pneumonia, prolonged mechanical ventilation (more than 24 hours), respiratory failure, ARDS).
Measured: The first seven postoperative days
Secondary outcomes (4)
The length of hospital stay in both groups
Measured: Up to 30 days postoperatively.
Assessment of the total amount of fluid administered intraoperatively in both groups
Measured: Intraoperatively (From the start to the end of the surgery)
Intraoperative vasopressor use in both groups
Measured: Intraoperatively (From the start to the end of the surgery)
Intraoperative hypotensive episodes in both groups
Measured: Intraoperatively (From the start to the end of the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 Jul 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad E Salama, MD, Suez Canal University
- Investigators
- Mohammad E Salama, MD, Principal investigator, Suez canal university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041021
- Sponsor's protocol ID
- 5988#
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanfilippo F, La Via L, Dezio V, Santonocito C, Amelio P, Genoese G, Astuto M, Noto A. Assessment of the inferior vena cava collapsibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on healthy volunteers. Intensive Care Med Exp. 2023 Apr 3;11(1):15. doi: 10.1186/s40635-023-00505-7.
PubMed 37009935Miller TE, Mythen M, Shaw AD, Hwang S, Shenoy AV, Bershad M, Hunley C. Association between perioperative fluid management and patient outcomes: a multicentre retrospective study. Br J Anaesth. 2021 Mar;126(3):720-729. doi: 10.1016/j.bja.2020.10.031. Epub 2020 Dec 13.
PubMed 33317803Ma GG, Hao GW, Yang XM, Zhu DM, Liu L, Liu H, Tu GW, Luo Z. Internal jugular vein variability predicts fluid responsiveness in cardiac surgical patients with mechanical ventilation. Ann Intensive Care. 2018 Jan 16;8(1):6. doi: 10.1186/s13613-017-0347-5.
PubMed 29340792Kan CFK, Skaggs JD. Current Commonly Used Dynamic Parameters and Monitoring Systems for Perioperative Goal-Directed Fluid Therapy: A Review. Yale J Biol Med. 2023 Mar 31;96(1):107-123. doi: 10.59249/JOAP6662. eCollection 2023 Mar.
PubMed 37009197Deslarzes P, Jurt J, Larson DW, Blanc C, Hubner M, Grass F. Perioperative Fluid Management in Colorectal Surgery: Institutional Approach to Standardized Practice. J Clin Med. 2024 Jan 30;13(3):801. doi: 10.3390/jcm13030801.
PubMed 38337495Dai S, Shen J, Tao X, Chen X, Xu L. Can ultrasonographic measurement of respiratory variability in the diameter of the internal jugular vein and the subclavian vein predict fluid responsiveness in parturients during cesarean delivery? A prospective cohort study. Heliyon. 2022 Dec 13;8(12):e12184. doi: 10.1016/j.heliyon.2022.e12184. eCollection 2022 Dec.
PubMed 36536919Kang D, Yoo KY. Fluid management in perioperative and critically ill patients. Acute Crit Care. 2019 Nov;34(4):235-245. doi: 10.4266/acc.2019.00717. Epub 2019 Nov 29.
PubMed 31795621Aaen AA, Voldby AW, Storm N, Kildsig J, Hansen EG, Zimmermann-Nielsen E, Jensen KM, Tibaek P, Mortensen A, Moller AM, Brandstrup B. Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial. Br J Anaesth. 2021 Oct;127(4):521-531. doi: 10.1016/j.bja.2021.06.031. Epub 2021 Aug 11.
PubMed 34389168
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Fluid Management Guided by Respiratory Variations of Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07041021
- Acronym / sponsor ID
- 5988#
- Conditions
- Postoperative Complications
- Keywords
- Postoperative Complications, Abdominal surgeries, Internal Jugular Vein, Intraoperative fluid therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
This study investigates the role of respiratory variation in the internal jugular vein as a tool for intraoperative fluid management during abdominal surgeries under general anesthesia.
The purpose of this clinical trial is to reduce postoperative complications and improve patient outcomes through proper intraoperative fluid management.
The main question it aims to answer is: Can intraoperative fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries reduce postoperative complications? Research Hypothesis (Alternative Hypothesis): We hypothesize that fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries can reduce postoperative complications.
The patients will be divided into two groups and randomized to receive either intraoperative fluid therapy guided by the respiratory variation of the internal jugular vein or standard fluid therapy. Postoperative complications, length of hospital stay, total amount of fluid administered intraoperatively, use of vasopressors in both groups, and incidence of hypotensive episodes will be recorded.
Detailed description
Sonographic measurement of respiratory variation of IJV will be performed with a Philips CX50 ultrasound device (Philips Healthcare, Hamburg, Germany), equipped with a linear transducer. Respiratory variation of IJV will be measured by the same anesthesiologist with sufficient experience in ultrasound guided IJV cannulation. The anesthesiologist performing the ultrasound examinations will not be involved in this study and blinded to the hemodynamic parameters; a lead plate separated the monitor from the anesthesiologist and ultrasound device. The optimal short axis of the IJV will be obtained at the level of the cricoid cartilage by placement of the transducer perpendicular to the skin on the patient's neck in a transverse plane. The vein will be identified with color Doppler imaging as well as by compression. Ultrasound measurements will be performed on the left IJV, M-mode scan will be used to record the IJV diameter at the end of inspiration (IJVmax) and expiration (IJVmin) over an entire respiratory cycle. The images will be then frozen. The respiratory variation of IJV will be calculated with the following formula: IJV RV (%) = (IJVmax - IJVmin)/ (IJVmin) × 100%. The average values of IJVmax and IJVmin from three consecutive respiratory circles will be used in the analysis.
The finding of a small-diameter IJV (<1cm) and increased IJV RV (>18) suggest low-volume states. Conversely, a large IJV diameter (>2.1cm) and decreased IJV RV (<18) will suggest a high-volume state.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Jugular Vein (IJV) group (Study group) | Active comparator | Diagnostic Test: Respiratory variation of the Internal Jugular Vein (IJV)In this group, fluid therapy will be guided by the respiratory variation of IJV throughout the surgery. |
| Control group | No intervention | –In this group, conventional fluid therapy will be given to ensure that the mean arterial blood pressure is equal to or more than 65 mmHg. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients' American Society of Anesthesiologists physical status (ASA) is I and II.
- The target age group is 20 to 70 years old.
- Patients scheduled for abdominal surgery under general anesthesia with normal renal function.
Key exclusion criteria (3 listed)
- Refusal of the procedure or participation in the study.
- Coagulopathy.
- Pre-existing cardiac, renal, and respiratory diseases. 4-Internal jugular vein thrombosis
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 |
|---|---|---|
| Respiratory variation of the Internal Jugular Vein (IJV)In the study group, the fluid therapy will be guided by the respiratory variation (RV) of the Internal Jugular Vein (IJV) throughout surgery. Fluid maintenance will be continued as long as the IJV diameter is less than 2 cm and the IJV RV is more than 18. If the IJV diameter exceeds 2 cm and the IJV RV is less than 18, fluids will be stopped. | Diagnostic test | Internal Jugular Vein (IJV) group (Study group) |
Primary outcome
The primary outcome is the incidence of postoperative complications in both groups, which will be measured by the occurrence of any of the postoperative complications during the first seven postoperative days in both groups
Time frame: The first seven postoperative days
Postoperative complications will include: (i) infections (urinary tract infection, wound infection, sepsis/septic shock) (ii) GI (Ileus, acute bowel obstruction, GI bleeding, abdominal compartment syndrome), (iii) Cardiovascular (deep venous thrombosis, pulmonary embolism, myocardial ischemia or infarction, cardiac arrest), (iv) Renal (AKI) (v) Respiratory (pneumonia, prolonged mechanical ventilation (more than 24 hours), respiratory failure, ARDS).
4 secondary outcomes
The length of hospital stay in both groups
Time frame: Up to 30 days postoperatively.
Assessment of the total amount of fluid administered intraoperatively in both groups
Time frame: Intraoperatively (From the start to the end of the surgery)
Intraoperative vasopressor use in both groups
Time frame: Intraoperatively (From the start to the end of the surgery)
Intraoperative hypotensive episodes in both groups
Time frame: Intraoperatively (From the start to the end of the surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 37009935Sanfilippo F, La Via L, Dezio V, Santonocito C, Amelio P, Genoese G, Astuto M, Noto A. Assessment of the inferior vena cava collapsibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on healthy volunteers. Intensive Care Med Exp. 2023 Apr 3;11(1):15. doi: 10.1186/s40635-023-00505-7.
- Results publication: PubMed 33317803Miller TE, Mythen M, Shaw AD, Hwang S, Shenoy AV, Bershad M, Hunley C. Association between perioperative fluid management and patient outcomes: a multicentre retrospective study. Br J Anaesth. 2021 Mar;126(3):720-729. doi: 10.1016/j.bja.2020.10.031. Epub 2020 Dec 13.
- Results publication: PubMed 29340792Ma GG, Hao GW, Yang XM, Zhu DM, Liu L, Liu H, Tu GW, Luo Z. Internal jugular vein variability predicts fluid responsiveness in cardiac surgical patients with mechanical ventilation. Ann Intensive Care. 2018 Jan 16;8(1):6. doi: 10.1186/s13613-017-0347-5.
- Results publication: PubMed 37009197Kan CFK, Skaggs JD. Current Commonly Used Dynamic Parameters and Monitoring Systems for Perioperative Goal-Directed Fluid Therapy: A Review. Yale J Biol Med. 2023 Mar 31;96(1):107-123. doi: 10.59249/JOAP6662. eCollection 2023 Mar.
- Results publication: PubMed 38337495Deslarzes P, Jurt J, Larson DW, Blanc C, Hubner M, Grass F. Perioperative Fluid Management in Colorectal Surgery: Institutional Approach to Standardized Practice. J Clin Med. 2024 Jan 30;13(3):801. doi: 10.3390/jcm13030801.
- Results publication: PubMed 36536919Dai S, Shen J, Tao X, Chen X, Xu L. Can ultrasonographic measurement of respiratory variability in the diameter of the internal jugular vein and the subclavian vein predict fluid responsiveness in parturients during cesarean delivery? A prospective cohort study. Heliyon. 2022 Dec 13;8(12):e12184. doi: 10.1016/j.heliyon.2022.e12184. eCollection 2022 Dec.
- Results publication: PubMed 31795621Kang D, Yoo KY. Fluid management in perioperative and critically ill patients. Acute Crit Care. 2019 Nov;34(4):235-245. doi: 10.4266/acc.2019.00717. Epub 2019 Nov 29.
- Results publication: PubMed 34389168Aaen AA, Voldby AW, Storm N, Kildsig J, Hansen EG, Zimmermann-Nielsen E, Jensen KM, Tibaek P, Mortensen A, Moller AM, Brandstrup B. Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial. Br J Anaesth. 2021 Oct;127(4):521-531. doi: 10.1016/j.bja.2021.06.031. Epub 2021 Aug 11.
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Mohammad E Salama, MD principal investigator
Suez canal university hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory variation of the Internal Jugular Vein (IJV) in people with Postoperative Complications, run by Suez Canal University at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad E Salama, MD (00201016865861, MohammadElhossieny88@med.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the incidence of postoperative complications in both groups, which will be measured by the occurrence of any of the postoperative complications during the first seven postoperative days in both groups (time frame: The first seven postoperative days). 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 NCT07041021, which also lists 8 linked publications.
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 7 Apr 2026.