Warm Humidified CO2 Insufflation for Gastric Bypass Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Narcotics, Steroids
Disqualifiers: Narcotics addiction, Paraplegic, Quadriplegic, Dementia, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to To determine the effect of warm and humidified (WH) carbon dioxide (CO2) on post-operative pain/analgesia requirement in patients undergoing laparoscopic bariatric surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking daily pain medications (narcotics) or steroids.
What data supports the effectiveness of the treatment Warm Humidified CO2 Insufflation for Gastric Bypass Surgery?
Research suggests that using warm humidified carbon dioxide (CO2) during laparoscopic gastric bypass surgery can reduce postoperative pain and the need for pain medication, as well as shorten recovery time compared to using cold dry CO2. This is because the warm humidified CO2 helps prevent hypothermia (abnormally low body temperature) and drying out of cells in the abdomen.12345
Is warm humidified CO2 insufflation safe for use in gastric bypass surgery?
What makes warm humidified CO2 insufflation unique in gastric bypass surgery?
Research Team
Erik B Wilson, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
This trial is for patients scheduled for elective bariatric surgery, including primary or revision procedures and hiatal hernia repairs. It's not specified who can't join the trial.Inclusion Criteria
elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo laparoscopic bariatric surgery using either warm humidified CO2 or dry CO2
1 day
1 visit (in-person)
Postoperative Care
Participants are monitored in the Post Anesthesia Care Unit (PACU) for analgesic requirements and temperature
Several hours
1 visit (in-person)
Follow-up
Participants are monitored for pain and analgesia requirements post-surgery
24 hours
Treatment Details
Interventions
- Dry CO2 (Device)
- Minimally Invasive Bariatric (Gastric Bypass) Surgery (Procedure)
- Warm humidified CO2 (Device)
Trial OverviewThe study compares two methods of insufflation (pumping gas to expand the abdomen) during laparoscopic bariatric surgery: one uses dry CO2, and the other uses warm humidified CO2. The goal is to see if warm humidified CO2 reduces post-operative pain and need for painkillers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Warm humidified CO2Experimental Treatment1 Intervention
Group II: Dry CO2Active Control1 Intervention
Minimally Invasive Bariatric (Gastric Bypass) Surgery is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Laparoscopic Gastric Bypass Surgery for:
- Obesity
- Type 2 Diabetes Mellitus
- Gastroesophageal Reflux Disease
🇺🇸 Approved in United States as Laparoscopic Gastric Bypass Surgery for:
- Obesity
- Type 2 Diabetes Mellitus
- Gastroesophageal Reflux Disease
- Sleep Apnea
🇨🇦 Approved in Canada as Laparoscopic Gastric Bypass Surgery for:
- Obesity
- Type 2 Diabetes Mellitus
- Gastroesophageal Reflux Disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Trials
974
Patients Recruited
361,000+
References
Prospective randomized trial of heated humidified versus cold dry carbon dioxide insufflation during laparoscopic gastric bypass. [2013]The replacement of cold dry carbon dioxide with heated humidified gas for insufflation during complex laparoscopic procedures has been reported to decrease hypothermia and peritoneal cell desiccation, with a resultant decrease in postoperative pain and narcotic use and a shortened recovery, but may prevent the paralysis of the peritoneal polymorphonuclear cell cytokine cascade and add to the cost of the procedure. We report our outcomes comparing carbon dioxide insufflation with different characteristics during laparoscopic gastric bypass.
Beneficial effects of humidified, warmed carbon dioxide insufflation during laparoscopic bariatric surgery: a randomized clinical trial. [2017]Recent data has shown that the use of warmed, humidified carbon dioxide (CO2) insufflation during laparoscopic surgery may be associated with better outcomes.
Helium pneumoperitoneum ameliorates hypercarbia and acidosis associated with carbon dioxide insufflation during laparoscopic gastric bypass in pigs. [2013]In the morbidly obese patient undergoing laparoscopic gastric bypass (LGBP), insufflation with carbon dioxide to 20 mmHg for prolonged periods may induce significant hypercarbia and acidosis with attendant sequelae. We hypothesize that the use of helium as an insufflating agent results in less hypercarbia and acidosis.
An assessment by calorimetric calculations of the potential thermal benefit of warming and humidification of insufflated carbon dioxide. [2014]Heat transfer from a patient to warm and humidify insufflated carbon dioxide (CO2) during laparoscopic surgery may contribute to perioperative hypothermia. The magnitude of this effect was calculated using calorimetric calculations. Warming to 37°C and humidifying to 100%, each 100 L of insufflated CO2 would prevent a heat transfer of 3220 calories, which would result in a decrease of temperature by 0.06°C in a 70 kg patient after total body distribution of heat. We conclude that the thermal benefit of warming and humidifying insufflated CO2 is minor, particularly in comparison with other effective and inexpensive perioperative technologies, some of which are not always used out could easily be used. The decision to use heating and humidification of insufflated CO2 should be based on its other risks, benefits, and costs.
High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. [2021]Minimally invasive bariatric procedures next to becoming more and more popular have established a new field of applications for carbon dioxide (CO2) insufflators. In laparoscopic bariatric procedures, gas is used to insufflate the peritoneal cavity and increase the intra-abdominal pressure up to 15 mm Hg for optimal exposure and a suitable operating field. The increased intra-abdominal pressure during pneumoperitoneum can reduce femoral venous flow, intra-operative urine output, portal venous flow, respiratory compliance,and cardiac output. However, clinical complications related to these effects are rare. Yet, surgeons should be constantly aware that the duration of an operation is an important factor in reducing the patient's exposure to CO2 pneumoperitoneum and its adverse effects. The optimized performance of the bariatric high flow insufflator allows reaching stable abdominal pressure conditions quicker and at a higher level than a common insufflator. Therefore, high flow insufflators offer great advantages in maintaining intra-abdominal pressure and temperature in comparison to conventional insufflators and thus enhance laparoscopic bariatric surgery by potentially reducing the operating time and the undesirable effects of CO2 pneumoperitoneum.
Laparoscopic gastric bypass for refractory morbid obesity. [2005]Morbid obesity has reached epidemic proportions in the United States. Laparoscopic gastric bypass is rapidly becoming the procedure of choice for treatment of morbid obesity. Results demonstrate that the surgery is technically safe. Outcomes are similar to open gastric bypass,but with markedly lower incidences of wound-related and cardiopulmonary complications. Patients also have shorter hospital stay, decreased pain and faster recovery.
Perforated gastric ulcer post mini gastric bypass treated by laparoscopy: A case report. [2022]Among the many techniques available for bariatric surgery, the Mini Gastric Bypass is a safe, technically simple and effective option. However, it may present with postoperative complications, being the perforated gastric ulcer one of the most relevant ones.
Gastric bypass. [2019]Gastric bypass in the very obese is a technically difficult and tedious procedure done in the attic of the peritoneal cavity. However, with careful attention to pre-, intra-, and postoperative detail, it is reasonably safe, effective, and relatively free from unmanageable complications.
Impact of temperature and humidity of carbon dioxide pneumoperitoneum on body temperature and peritoneal morphology. [2019]The insufflation of cold gas during laparoscopic surgery exposes patients to the risk for hypothermia. The objectives of this study were to investigate whether heating or humidification of insufflation gas could prevent peroperative hypothermia in a rat model, and to assess whether the peritoneum was affected by heating or humidification of the insufflation gas.
Warmed and humidified carbon dioxide for abdominal laparoscopic surgery: meta-analysis of the current literature. [2018]Label="BACKGROUND">The creation of a pneumoperitoneum for laparoscopic surgery is performed by the insufflation of carbon dioxide (CO2). The insufflated CO2 is generally at room temperature (20-25 °C) and dry (0-5 % relative humidity). However, these physical characteristics could lead to alterations of the peritoneal cavity, leading to operative and postoperative complications. Warming and humidifying the insufflated gas has been proposed to reduce the iatrogenic effects of laparoscopic surgery, such as pain, hypothermia and peritoneal alterations. Two medical devices are currently available for laparoscopic surgery with warm and humidified CO2.