Postoperative Nausea and VomitingiMODIPONVNCT03641625
Effect of SmtO2 Guided Care on PONV (iMODIPONV)
A study testing Muscular tissue oxygen saturation guided care in people with Postoperative Nausea and Vomiting and Hysterectomy, run by Yale University at 1 site in China.
Trial summary
This randomized controlled trial is to investigate if SmtO2-guided management on top of the usual care, compared with the usual care only, during laparoscopic hysterectomy significantly reduces the incidence of PONV. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Hysterectomy, Tissue Oxygenation
- What is being tested?
- Muscular tissue oxygen saturation guided care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2018to 31 Jul 2019
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Non-smoker
- ASA I-III
- Elective laparoscopic procedure involving hysterectomy
Who cannot join
- Refuse to participate
- Emergent surgery
- Bowel resection planned
- Vaginal or abdominal (open) hysterectomy
- Chemotherapy or radiotherapy before surgery
- Significant neuro, cognitive, or psychologic disease: stroke with neurologic deficit, dementia, schizophrenia, or any condition that makes meaningful postoperative follow-ups impossible
Show all 14Show fewer
- Significant cardiovascular disease: low-output cardiac failure defined as a preoperative left ventricular ejection fraction < 30%, active coronary artery disease, symptomatic valvular disease, symptomatic arrhythmia with or without pacemaker and/or AICD placement
- Significant pulmonary disease: COPD requiring home oxygen therapy, severe asthma requiring steroid treatment, other pulmonary conditions requiring home oxygen therapy
- Severe hepatic dysfunction being evaluated for liver transplantation or with a Child-Pugh Class C classification
- Severe renal dysfunction requiring renal replacement therapy
- Muscular pathologies such as dystrophy, atrophy, and weakness
- Skin conditions incompatible with the adhesive oximetry probe (e.g., delicate or tattooed skin)
- Current or previous smoker
- ASA Physical Score ≥ IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Muscular Tissue Oxygen Saturation-Guided Management During Laparoscopic Hysterectomy on Postoperative Nausea and Vomiting: A Randomized Controlled Trial (iMODIPONV)
This randomized controlled trial is to investigate if SmtO2-guided management on top of the usual care, compared with the usual care only, during laparoscopic hysterectomy significantly reduces the incidence of PONV.
Read the detailed description
Postoperative nausea and vomiting (PONV) remains prevalent despite the institution of various prophylactic measures. The incidence of PONV in female patients undergoing laparoscopic gynecological surgery is up to 50% with and 70% without the administration of antiemetics, respectively. The consequences of PONV range from patient discomforts, postoperative complications, prolonged hospitalization, to increased health care costs. Among the multiple risk factors, suboptimal gastrointestinal (GI) perfusion or oxygenation may be responsible for some cases of PONV; however, this speculation remains to be confirmed.5 Optimal tissue oxygenation, the balance between tissue oxygen consumption and supply, is essential for the integrity of any tissue bed that is metabolically active. However, GI oxygenation cannot be directly and continuously monitored in patients at this time. Whether there is an organ which can be used as a surrogate of the GI system, meaning that the tissue oxygenation of this surrogate organ not only can be monitored and that it also correlates with that of the GI system, is an intriguing question. Currently, tissue oxygenation can be measured using near-infrared spectroscopy (NIRS) in patients. The recent advancements of this technology enable the accurate monitoring of the oxygenation within many tissue beds depending on the location of the oximetry probe.
The recent cohort study demonstrated that there is a close relationship between muscular tissue oxygen saturation (SmtO2) and PONV in patients undergoing robotic laparoscopic hysterectomy (manuscript accepted and in production). Multiple thresholds based on threshold, AUC, and multivariable analyses are able to differentiate the risk of PONV. The following SmtO2 thresholds were found to correlate with a reduced risk of PONV: 20% above baseline; while the following thresholds correlate with an increased risk of PONV: 5% below baseline, 15% below baseline, and 20% below baseline, < 70%, < 65%, and < 60%. Taken together, our study suggests the potential therapeutic targets for PONV prophylaxis may be to maintain SmtO2 > 70% and above baseline.
In this study, the investigators aim to investigate if intraoperative care guided by SmtO2 monitoring reduces the incidence of PONV after laparoscopic hysterectomy.
- Conditions
- Postoperative Nausea and Vomiting, Hysterectomy, Tissue Oxygenation, Cardiac Output Management, Blood Pressure Management
- Being tested
- Muscular tissue oxygen saturation guided care
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Hysterectomy, Muscular Tissue Oxygen Saturation, Hemodynamic Management
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular tissue oxygen saturation guided careDevice
Muscular tissue oxygen saturation monitored at flank and arm will be maintained > 70% (absolute measurement) and > baseline throughout the entire procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to usual care during surgery, the intraoperative management will be additionally managed based on the guidance of muscular tissue oxygen saturation and non-invasive hemodynamic monitoring. Receives: Device: Muscular tissue oxygen saturation guided care |
| Control | No intervention | Patients will receive the usual care. Muscular tissue oxygen saturation and non-invasive hemodynamic monitoring will be used but blinded to care givers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV within 24 hours after surgery
Nausea: Nausea is defined as a subjective unpleasant sensation associated with the urge to vomit.
Retching: Retching is defined as the labored, spastic, and rhythmic contraction of chest and abdominal muscles without expulsion of gastric contents.
Vomiting: Vomiting is defined as the forceful expulsion of any gastric contents from the mouth.
PONV: PONV refers to the occurrence of nausea, retching, and/or vomiting.
Measured: up to 24 hours
Secondary outcomes (11)
Incidence of early PONV
The incidence of PONV during postoperative 0-6 hours. The diagnostic criteria for early PONV are the same as above (outcome 1).
Measured: up to 6 hours
Severity of postoperative pain
Postoperative pain intensity at rest and with movement expressed using NRS 0-10 (0 = no pain; 10 = worst pain) at 2, 6, and 24 h depending on the time to discharge
Measured: up to 24 hours
Time of GI recovery
Time to GI recovery (time to first flatus, bowel motion, and/or time to tolerate oral diet, in hours)
Measured: up to 48 hours
Overall quality of recovery based on QoR-15 questionnaire
Postoperative quality of recovery
(using the QoR-15 questionnaire)
QoR-15 Questions PART A How have you been feeling in the last 24 hours? (0 to 10, where 0 = none of the time [poor] and 10 = all of the time [excellent] Q.1 Able to breathe easily Q.2 Been able to enjoy food Q.3 Feeling rested Q.4 Have had a good sleep Q.5 Able to look after personal toilet and hygiene unaided Q.6 Able to communicate with family or friends Q.7 Getting support from hospital doctors and nurses Q.8 Able to return to work or usual home activities Q.9 Feeling comfortable and in control Q.10 Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where 10 = none of the time [excellent] and 0 = all of the time [poor]) Q.11 Moderate pain Q.12 Severe pain Q.13 Nausea or vomiting Q.14 Feeling worried or anxious Q.15 Feeling sad or depressed
Measured: up to 24 hours
Time to mobilization
Time to mobilization (time to first out-of-bed mobilization, in hours)
Measured: up to 48 hours
Score of sleep quality
Postoperative sleep quality (using NRS 0-10 (0 = no concern at all; 10 = worst ever) for the first night or the second night if the case is finished after 6pm)
Measured: up to 48 hours
In-hospital GI complications
In-hospital GI-related composite complication (composite of ileus, obstruction, perforation, and bleeding)
Measured: up to 30 days
Non-GI-related composite complications
Both in-hospital and 30-day non-GI-related composite complications (Complication was defined as any deviation from the normal postoperative course or organ dysfunction.[23-25] Organ-specific complications include myocardial infarction, congestive heart failure, cardiac arrest, atrial fibrillation or other types of arrhythmia, pulmonary embolus, pneumonia treated with antibiotics, respiratory failure requiring intubation, respiratory insufficiency requiring physiotherapy or oxygen therapy, stroke, transient ischemic attack, postoperative delirium or cognitive decline, renal insufficiency requiring dialysis, acute kidney injury, urinary tract infection requiring antibiotics, hepatic insufficiency, gut hypoperfusion, ileus, disseminated intravascular coagulation, and sepsis. Surgery-related complications refer to surgical site bleeding, infection, anastomotic leakage, stenosis, ischemia, or tissue necrosis.)
Measured: up to 30 days
Length of hospital stay
Length of hospital stay, in days
Measured: up to 30 days
Rate of ICU admission
The percentage of patients admitted to ICU after surgery
Measured: Up to 30 days
30-day mortality
30-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start15 Sep 2018
- Primary completion29 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Yale 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
- Model description
- International, multi-center, pragmatic, randomized controlled (1:1 ratio) trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Peking University First Hospital, Peking University Third Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, Beijing Obstetrics and Gynecology Hospital
- Responsible party
- Principal investigator, Lingzhong Meng, Yale University
- Investigators
- Lingzhong Meng, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641625
- Sponsor's protocol ID
- RCT_SmtO2_PONV
- Acronym
- iMODIPONV
- Status last verified
- Sep 2019
- First submitted
- 27 Jul 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data are available to the editorial office of the journal to which the manuscript is submitted upon request.
Publications
Geng ZY, Liu YF, Wang SS, Wang DX. Intra-operative dexmedetomidine reduces early postoperative nausea but not vomiting in adult patients after gynaecological laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Oct;33(10):761-6. doi: 10.1097/EJA.0000000000000491.
PubMed 27307217Gan TJ, Mythen MG. Does peroperative gut-mucosa hypoperfusion cause postoperative nausea and vomiting? Lancet. 1995 Apr 29;345(8957):1123-4. doi: 10.1016/s0140-6736(95)90857-9. No abstract available.
PubMed 7715373Meng L, Xiao J, Gudelunas K, Yu Z, Zhong Z, Hu X. Association of intraoperative cerebral and muscular tissue oxygen saturation with postoperative complications and length of hospital stay after major spine surgery: an observational study. Br J Anaesth. 2017 Apr 1;118(4):551-562. doi: 10.1093/bja/aex008.
PubMed 28403400Zhao X, Liao K, Wang W, Xu J, Meng L. Can a deep learning model based on intraoperative time-series monitoring data predict post-hysterectomy quality of recovery? Perioper Med (Lond). 2021 Apr 6;10(1):8. doi: 10.1186/s13741-021-00178-4.
PubMed 33820562
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscular Tissue Oxygen Saturation-Guided Management During Laparoscopic Hysterectomy on Postoperative Nausea and Vomiting: A Randomized Controlled Trial (iMODIPONV)
- ClinicalTrials.gov ID
- NCT03641625
- Acronym / sponsor ID
- iMODIPONV / RCT_SmtO2_PONV
- Conditions
- Postoperative Nausea and Vomiting, Hysterectomy, Tissue Oxygenation, Cardiac Output Management, Blood Pressure Management
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Hysterectomy, Muscular Tissue Oxygen Saturation, Hemodynamic Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Peking University First Hospital, Peking University Third Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, Beijing Obstetrics and Gynecology Hospital
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 22 Aug 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.
This randomized controlled trial is to investigate if SmtO2-guided management on top of the usual care, compared with the usual care only, during laparoscopic hysterectomy significantly reduces the incidence of PONV.
Detailed description
Postoperative nausea and vomiting (PONV) remains prevalent despite the institution of various prophylactic measures. The incidence of PONV in female patients undergoing laparoscopic gynecological surgery is up to 50% with and 70% without the administration of antiemetics, respectively. The consequences of PONV range from patient discomforts, postoperative complications, prolonged hospitalization, to increased health care costs. Among the multiple risk factors, suboptimal gastrointestinal (GI) perfusion or oxygenation may be responsible for some cases of PONV; however, this speculation remains to be confirmed.5 Optimal tissue oxygenation, the balance between tissue oxygen consumption and supply, is essential for the integrity of any tissue bed that is metabolically active. However, GI oxygenation cannot be directly and continuously monitored in patients at this time. Whether there is an organ which can be used as a surrogate of the GI system, meaning that the tissue oxygenation of this surrogate organ not only can be monitored and that it also correlates with that of the GI system, is an intriguing question. Currently, tissue oxygenation can be measured using near-infrared spectroscopy (NIRS) in patients. The recent advancements of this technology enable the accurate monitoring of the oxygenation within many tissue beds depending on the location of the oximetry probe.
The recent cohort study demonstrated that there is a close relationship between muscular tissue oxygen saturation (SmtO2) and PONV in patients undergoing robotic laparoscopic hysterectomy (manuscript accepted and in production). Multiple thresholds based on threshold, AUC, and multivariable analyses are able to differentiate the risk of PONV. The following SmtO2 thresholds were found to correlate with a reduced risk of PONV: 20% above baseline; while the following thresholds correlate with an increased risk of PONV: 5% below baseline, 15% below baseline, and 20% below baseline, < 70%, < 65%, and < 60%. Taken together, our study suggests the potential therapeutic targets for PONV prophylaxis may be to maintain SmtO2 > 70% and above baseline.
In this study, the investigators aim to investigate if intraoperative care guided by SmtO2 monitoring reduces the incidence of PONV after laparoscopic hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- International, multi-center, pragmatic, randomized controlled (1:1 ratio) trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Muscular tissue oxygen saturation guided careIn addition to usual care during surgery, the intraoperative management will be additionally managed based on the guidance of muscular tissue oxygen saturation and non-invasive hemodynamic monitoring. |
| Control | No intervention | –Patients will receive the usual care. Muscular tissue oxygen saturation and non-invasive hemodynamic monitoring will be used but blinded to care givers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Non-smoker
- ASA I-III
- Elective laparoscopic procedure involving hysterectomy
Key exclusion criteria (14 listed)
- Refuse to participate
- Emergent surgery
- Bowel resection planned
- Vaginal or abdominal (open) hysterectomy
- Chemotherapy or radiotherapy before surgery
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 |
|---|---|---|
| Muscular tissue oxygen saturation guided careMuscular tissue oxygen saturation monitored at flank and arm will be maintained > 70% (absolute measurement) and > baseline throughout the entire procedure. | Device | Intervention |
Primary outcome
Incidence of PONV within 24 hours after surgery
Time frame: up to 24 hours
Nausea: Nausea is defined as a subjective unpleasant sensation associated with the urge to vomit. Retching: Retching is defined as the labored, spastic, and rhythmic contraction of chest and abdominal muscles without expulsion of gastric contents. Vomiting: Vomiting is defined as the forceful expulsion of any gastric contents from the mouth. PONV: PONV refers to the occurrence of nausea, retching, and/or vomiting.
11 secondary outcomes
Incidence of early PONV
Time frame: up to 6 hours
Severity of postoperative pain
Time frame: up to 24 hours
Time of GI recovery
Time frame: up to 48 hours
Overall quality of recovery based on QoR-15 questionnaire
Time frame: up to 24 hours
Time to mobilization
Time frame: up to 48 hours
Score of sleep quality
Time frame: up to 48 hours
In-hospital GI complications
Time frame: up to 30 days
Non-GI-related composite complications
Time frame: up to 30 days
Length of hospital stay
Time frame: up to 30 days
Rate of ICU admission
Time frame: Up to 30 days
30-day mortality
Time frame: 30 days
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 25 Sep 2019.
- Background: PubMed 27307217Geng ZY, Liu YF, Wang SS, Wang DX. Intra-operative dexmedetomidine reduces early postoperative nausea but not vomiting in adult patients after gynaecological laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Oct;33(10):761-6. doi: 10.1097/EJA.0000000000000491.
- Background: PubMed 7715373Gan TJ, Mythen MG. Does peroperative gut-mucosa hypoperfusion cause postoperative nausea and vomiting? Lancet. 1995 Apr 29;345(8957):1123-4. doi: 10.1016/s0140-6736(95)90857-9. No abstract available.
- Background: PubMed 28403400Meng L, Xiao J, Gudelunas K, Yu Z, Zhong Z, Hu X. Association of intraoperative cerebral and muscular tissue oxygen saturation with postoperative complications and length of hospital stay after major spine surgery: an observational study. Br J Anaesth. 2017 Apr 1;118(4):551-562. doi: 10.1093/bja/aex008.
- Derived from this study: PubMed 33820562Zhao X, Liao K, Wang W, Xu J, Meng L. Can a deep learning model based on intraoperative time-series monitoring data predict post-hysterectomy quality of recovery? Perioper Med (Lond). 2021 Apr 6;10(1):8. doi: 10.1186/s13741-021-00178-4.
- Individual participant dataSharing planned: Undecided. Individual participant data are available to the editorial office of the journal to which the manuscript is submitted upon request.
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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.
Lingzhong Meng, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscular tissue oxygen saturation guided care in people with Postoperative Nausea and Vomiting and Hysterectomy, run by Yale University at 1 site in China.
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 14 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 25 Sep 2019. 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 China. 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?
Incidence of PONV within 24 hours after surgery (time frame: up to 24 hours). 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 NCT03641625, which also lists 4 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 25 Sep 2019.