An interventional study of Cold and dry CO2 pneumoperitoneum and Warm and humidified CO2 pneumoperitoneum in Pneumoperitoneum, sponsored by Northwell Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-27.
Sponsored by Northwell Health · Not applicable, Interventional, and Supportive care
Laparoscopic surgery (surgery with the use of a camera and small instruments) uses insufflation, which is the standard medical practice where CO2 (carbon dioxide) gas is blown into the abdomen to create space for surgical procedures. The purpose of this study is to investigate whether heating and humidifying surgical CO2 will reduce surgery-related inflammation and postoperative pain.
This is a prospective, randomized controlled trial in which 120 patients undergoing elective laparoscopic colorectal resection will either undergo insufflation of the peritoneum with cold and dry (CD), control or warm and humidified (WH) CO2, experimental. Patients scheduled to undergo elective Laparoscopic Colon Resection (LCR) will be informed about the study and all questions answered. Consenting patients will be randomized (via envelope system) to have either standard cold (19-21°C) and nonhumidified (0%) CO2 or warm (37°C) and humidified (95%) CO2 utilized for their resection. To ensure that similar numbers of rectal resection patients are in each group, a separate envelop randomization will be used for colectomy and rectal resection cases.
The study will be conducted at Mount Sinai West hospital. The ambient operating room temperature will be regulated to 70-72° F. All patients will undergo laparoscopic surgery. During laparoscopic surgery the camera and instruments are inserted into the abdomen via small incisions allowing for the surgeon to explore the whole abdominal cavity without making larger cuts. In order to create space for surgical procedures, insufflation with CO2 is used. Regarding the method of insufflation, subjects will be randomized into 2 groups: i) standard CD CO2 insufflation ii) Lexion Insuflow device providing warmed humidified CO2 insufflation (95° F and 95% relative humidity) The humidification and warming device to be used is the Insuflow Synergy Port (Lexion Company, FDA approved) which is a specialized 5 mm port that delivers warmed (95° F) and humidified (95% relative humidity) CO2, the source of which is a standard CO2 tank or wall source. This study was conceived and designed by the PI who approached Lexion seeking devices for the study. The company will provide no funds for the study and the data and all decision regarding presentation and publications are to be made by Mount Sinai West research team.
Study patients will receive anesthesia according to the following regimen (Mount Sinai West anesthesia department has suggested this regimen and has agreed to abide by it for LCR patients unless there is a contraindication to this approach in a given patient): Induction anesthesia will include IV midazolam, IV fentanyl (3-5 mcg/kg), IV propofol, IV rocuronium, perioperative IV antibiotics, IV ondansetron for nausea prophylaxis, IV dexamethasone (8mg), IV acetaminophen 1000mg, and IV ketorolac 15 mg. Maintenance anesthesia will included IV fentanyl (1-2 mcg/kg/hr), sevoflurane or desflurane inhalational agent, and 100% oxygen. Fentanyl doses can be increased at the discretion of the anesthesiologist. 30-40 minutes before the end of the procedure, the intraoperative narcotics will be discontinued and hydromorphone PCA will be started. Patients will receive hydromorphone in the post anesthesia care unit according to the discretion of the anesthesiologist.
Analysis: Data will be recorded by the Study RN and/or the research resident on a daily basis on Case Report Forms (paper) which will be entered into a HIPPA compliant dedicated study data base with access limited to study personnel and our data manager. The Non-parametric and parametric tests such as Kruskal-Wallis test and Analysis of Variance test shall be used to determine the impact of warm humidified vs cold dry CO2 on postoperative pain medication requirements as well as on other operative and short term clinical outcomes.
134 studies on the registry are indexed under Pneumoperitoneum; 28 are open to participants now.
Browse Pneumoperitoneum studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pneumoperitoneum is created by insufflation of standard cold (19-21°C) and nonhumidified (0%) CO2 directly from a standard CO2 tank or wall source.
Device: Cold and dry CO2 pneumoperitoneum
The humidification and warming device to be used is the Insuflow Synergy Port (Lexion Company, FDA approved) which is a specialized 5 mm port that delivers warmed (95° F) and humidified (95% relative humidity) CO2, the source of which is a standard CO2 tank or wall source.
Device: Warm and humidified CO2 pneumoperitoneum
In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.
In this arm, patients undergo pneumoperitoneum by the insufflation of warmed (95° F) and humidified (95% relative humidity) CO2, using a Lexion Insuflow device.
Also known as: Lexion Insuflow device
Number of pain medications taken postoperatively
The number of pain medications administered while hospitalized postoperatively will be tracked and recorded.
Time frame: up to 7 days
Timing of pain medications taken postoperatively
The timing of pain medications administered while hospitalized postoperatively will be tracked and recorded.
Time frame: up to 7 days
Postoperative pain levels
Postoperatively, pain levels (visual analog hospital pain scale) will be measured and recorded. scale from no pain (0) to worse pain (10).
Time frame: up to 21 days
Number of pain medications taken after discharge
Patients will likewise record the type and number of pain medications taken after discharge.
Time frame: up to 21 days
Intraoperative narcotic use
Time frame: Day 1
Analgesia requirements in the post anesthesia care unit
Time frame: Day 1
Volume of CO2 consumed during surgery
CO2 gas volumes required for LCR
Time frame: Day 1
Length of stay
Time frame: up to 21 days
Time to first flatus
Time frame: up to 21 days
Time to first bowel movement
Time frame: up to 21 days
Time to solid diet
Time frame: up to 21 days
Postoperative complications
Time frame: up to 21 days
Duration of Surgery
Time frame: Day 1
Incision length
Time frame: Day 1
Plan to share: No
Start is estimated for Jan 2023; primary completion for Sep 2024, 20 months later.
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This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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