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Warm and Humidified vs Cold and Dry Carbon Dioxide (CO2) Pneumoperitoneum

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ClinicalTrials.gov Identifier: NCT03330067
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumoperitoneum Device: Cold and dry CO2 pneumoperitoneum Device: Warm and humidified CO2 pneumoperitoneum Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Before surgery patients will be assigned to one of two types of CO2 gas (conventional-room temperature and dry, or conditioned-95°F and 95% humidity) by a method similar to the flip of a coin.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Warm and Humidified vs Cold and Dry Dry Carbon Dioxide (CO2) Pneumoperitoneum in Minimally Invasive Colorectal Resection: A Randomized Controlled Trial and Study of Clinical Endpoints
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Cold and dry CO2 pneumoperitoneum
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
In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.

Experimental: Warm and humidified 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 warmed (95° F) and humidified (95% relative humidity) CO2, using a Lexion Insuflow device.
Other Name: Lexion Insuflow device




Primary Outcome Measures :
  1. Number of pain medications taken postoperatively [ Time Frame: up to 7 days ]
    The number of pain medications administered while hospitalized postoperatively will be tracked and recorded.

  2. Timing of pain medications taken postoperatively [ Time Frame: up to 7 days ]
    The timing of pain medications administered while hospitalized postoperatively will be tracked and recorded.


Secondary Outcome Measures :
  1. Postoperative pain levels [ Time Frame: up to 21 days ]
    Postoperatively, pain levels (visual analog hospital pain scale) will be measured and recorded. scale from no pain (0) to worse pain (10).

  2. Number of pain medications taken after discharge [ Time Frame: up to 21 days ]
    Patients will likewise record the type and number of pain medications taken after discharge.

  3. Intraoperative narcotic use [ Time Frame: Day 1 ]
  4. Analgesia requirements in the post anesthesia care unit [ Time Frame: Day 1 ]
  5. Volume of CO2 consumed during surgery [ Time Frame: Day 1 ]
    CO2 gas volumes required for LCR

  6. Length of stay [ Time Frame: up to 21 days ]
  7. Time to first flatus [ Time Frame: up to 21 days ]
  8. Time to first bowel movement [ Time Frame: up to 21 days ]
  9. Time to solid diet [ Time Frame: up to 21 days ]
  10. Postoperative complications [ Time Frame: up to 21 days ]
  11. Duration of Surgery [ Time Frame: Day 1 ]
  12. Incision length [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective laparoscopic colorectal resection (LCR) for all indications (cancer, diverticular disease, benign neoplasm, inflammatory bowel disease, etc)

Exclusion Criteria:

  • Patients younger than 18 and older than 85, emergency surgery, reoperation within 30 days, patients who are taking pain medications (either NSAID's or narcotics) on a daily basis preoperatively for whatever reason, patients with a history of narcotics addiction, paraplegic and quadriplegic patients, patients with dementia or altered mental status, and patients on steroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330067


Contacts
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Contact: Richard Whelan, MD 212-523-8172 richard.whelan@mountsinai.org
Contact: Vesna Cekic, BN 212-523-8065 vesna.cekic@mountsinai.org

Locations
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United States, New York
Mount Sinai West Hospital Not yet recruiting
New York, New York, United States, 10019
Contact: Vesna Cekic Cekic, BN    212-523-8065    vesna.cekic@mountsinai.org   
Principal Investigator: Richard Whelan, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Richard Whelan, MD Icahn School of Medicine at Mount Sinai

Publications:

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03330067     History of Changes
Other Study ID Numbers: GCO 16-2223
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
laparoscope

Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases