Effect of SmtO2 Guided Care on PONV (iMODIPONV)

NCT03641625 | Completed DMC

• 1 other identifier: RCT_SmtO2_PONV
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 hours

Secondary Outcomes (11)

• Incidence of early PONV

  up to 6 hours

• Severity of postoperative pain

  up to 24 hours

• Time of GI recovery

  up to 48 hours

• Overall quality of recovery based on QoR-15 questionnaire

  up to 24 hours

• Time to mobilization

  up to 48 hours

Study Arms (2)

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.

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.

Interventions

Muscular tissue oxygen saturation guided care DEVICE

Muscular tissue oxygen saturation monitored at flank and arm will be maintained \> 70% (absolute measurement) and \> baseline throughout the entire procedure.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: It is female patients whom are receiving hysterectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Non-smoker
• ASA I-III
• Elective laparoscopic procedure involving hysterectomy

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yale University: lead
• The Second Hospital of Hebei Medical University: collaborator
• Peking University First Hospital: collaborator
• Peking University Third Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (4)

• 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.

  PMID: 27307217 BACKGROUND

• Gan 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.

  PMID: 7715373 BACKGROUND

• Meng 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.

  PMID: 28403400 BACKGROUND

• Zhao 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.

  PMID: 33820562 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Lingzhong Meng, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both patients and outcomes assessor are blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Division Chief

Model Details: International, multi-center, pragmatic, randomized controlled (1:1 ratio) trial

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 22, 2018
• Study Start: September 15, 2018
• Primary Completion: June 29, 2019
• Study Completion: July 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

CN (1)