Low Gas Pressure vs Standard Gas Pressure in Weight-Loss Surgery
Comparison Between Low Pressure (8 mmHg) AirSeal Insufflation vs Standard Pressure (15 mmHg) Pneumoperitoneum on Postoperative Recovery in Bariatric Surgery: A Randomized Controlled Trial
During weight-loss surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery.
The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during weight-loss surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.
The study includes adults aged 18 or older having robotic weight-loss surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) at New York-Presbyterian Hospital/Weill Cornell Medical Center.
The main questions this clinical trial aims to answer are:
- Does using lower gas pressure shorten the time people spend in the recovery room after surgery?
- Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Minimally invasive bariatric surgeries require the use of pneumoperitoneum, which is a standard of care as it creates a working environment to utilize minimally invasive tools to accomplish surgical procedures. However, there is no uniform standard pressure (usually between 12-15 mmHg). Moreover, maintaining the same pressure throughout the procedure can be inconsistent at best. Elevations in pneumoperitoneum cause significant stretch to the peritoneum which results in significant postoperative pain, longer post-anesthesia care unit (PACU) stay times, and higher opioid consumption. These effects are amplified to a higher degree in patients with severe obesity. If the pressures can be maintained and set to lower levels, then patients may have the opportunity to recover in the immediate postoperative period.
The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery.
This study is a prospective, single-center, single-blind, double-arm parallel-group randomized controlled trial that aims to determine if the use of low-pressure (8 mmHg) AirSeal insufflation, compared to standard-pressure (15 mmHg) pneumoperitoneum, provides superior patient outcomes in terms of post-operative recovery time and convalescence.
During the preoperative evaluation, participants will be consented and enrolled into the trial. Participants will then be randomly allocated to either low-pressure AirSeal insufflation (8 mmHg) or standard-pressure pneumoperitoneum (15 mmHg). Patients and outcome assessors will be blinded to allocation; however, for safety purposes, the operating surgeon and anesthesiologist cannot be blinded.
Intraoperative data (including operation time, estimated blood loss, abdominal pressure, and pressure deviations) will be recorded. Participant data related to comorbidities (i.e. body mass index, American Society of Anesthesiologists physical status, hypertension, diabetes, obstructive sleep apnea, chronic obstructive pulmonary disease/asthma, and smoking status) will be collected from the electronic medical record.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cheguevara Afaneh, MD
- Número de teléfono: (646) 962-8462
- Correo electrónico: cha9043@med.cornell.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery
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Investigador principal:
- Cheguevara Afaneh, MD
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Contacto:
- Cheguevara Afaneh, MD
- Número de teléfono: (646) 962-8462
- Correo electrónico: cha9043@med.cornell.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged 18 years or older
- Scheduled to undergo robotic-assisted Roux-en-Y gastric bypass or sleeve gastrectomy at New York-Presbyterian/Weill Cornell Medical Center
- Obesity (body mass index≥40kg/m2 or ≥35kg/m2 with serious obesity-related health conditions)
- American Society of Anesthesiologists physical status I-III
- Able to understand and provide written informed consent in English
Exclusion Criteria:
- American Society of Anesthesiologists physical status IV or higher (i.e. a severe systemic disease that is a constant threat to life such as decompensated heart failure)
- Chronic opioid use (≥30 morphine milligram equivalents per day for ≥30 days within the past 6 months)
- Current pregnancy
- Inability to understand and provide informed consent in English
- Inability to provide informed consent due to cognitive impairment or other conditions impacting decision-making capacity
- Scheduled open or laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Low-pressure pneumoperitoneum (AirSeal)
Participants who are assigned to this arm will receive 8 mmHg pneumoperitoneum using the AirSeal Robotic Solution device. The AirSeal Robotic Solution device is a FDA 510(k)-cleared carbon dioxide insufflation platform with valveless trocar technology that helps to maintain stable intra-abdominal pressure during surgery. |
The experimental intervention is low-pressure pneumoperitoneum at 8 mmHg using the AirSeal Robotic Solution device. The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery. It consists of a console, tri-lumen filtered tube set, and access ports that function as valveless trocars. The console of the device is mounted on a cart and regulates carbon dioxide flow and smoke evacuation by continuously measuring the intra-abdominal pressure. The trilumen filtered tube set carries carbon dioxide to the abdomen, transmits pressure information back to the console, and returns gas from the abdomen for smoke evacuation and filtration. These features allow for the device to operate in the "AirSeal" mode, whereby the pressure within the abdomen is effectively kept constant. The valveless trocars are access ports for the minimally invasive tools to enter the abdominal cavity. |
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Comparador activo: Standard-pressure pneumoperitoneum
Participants who are assigned to this arm will receive 15 mmHg pneumoperitoneum using the conventional insufflation machine at New York-Presbyterian/Weill Cornell Medical Center.
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The control intervention is standard-pressure pneumoperitoneum set at a pressure of 15 mmHg.
This will be delivered using the operating room's conventional valved-trocar carbon dioxide insufflator.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order
Periodo de tiempo: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)
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The PACU is the area where participants recover from anesthesia after surgery. The PACU recovery time will be computed in minutes as the interval between the documented PACU arrival timestamp and the documented PACU discharge-order timestamp which will both be abstracted from the institutional electronic medical record. The discharge-order timestamp represents the clinical decision that the participant is fit to leave the PACU and is therefore not confounded by factors such as transport delays. |
From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average numeric rating scale (NRS) pain score (0-10) at PACU admission
Periodo de tiempo: PACU arrival (5 minutes post-surgery)
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Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the participants within 5 minutes of documented PACU arrival. |
PACU arrival (5 minutes post-surgery)
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Average numeric rating scale (NRS) pain score (0-10) at PACU discharge
Periodo de tiempo: PACU discharge (1-4 hours post-surgery)
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Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the participants within 10 minutes of PACU discharge order time stamp. |
PACU discharge (1-4 hours post-surgery)
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Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1)
Periodo de tiempo: Post-operative day 1 (24 hours after surgery)
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Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the participants on POD1 between the hours of 08:00 and 12:00. If the participant is discharged, a telephone call will be made during those hours. |
Post-operative day 1 (24 hours after surgery)
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Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3)
Periodo de tiempo: Post-operative day 3 (72 hours after surgery)
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Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the patients on POD3 between the hours of 08:00 and 12:00. If the participant is discharged, a telephone call will be made during those hours. |
Post-operative day 3 (72 hours after surgery)
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Average morphine milligram equivalents (MME) in the post-anesthesia care unit (PACU)
Periodo de tiempo: PACU arrival to PACU discharge (1-4 hours post-surgery)
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Cumulative opioid consumption will be measured using morphine milligram equivalents (MME) which will convert all administered opioids regardless of agent or route of administration to an equivalent amount of oral morphine using standard conversion factors. Opioid dosage data will be abstracted from the electronic medical record. The total MME administered between the PACU arrival timestamp and the documented PACU discharge-order timestamp will be recorded. A lower cumulative MME indicates less opioid requirements. |
PACU arrival to PACU discharge (1-4 hours post-surgery)
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Average morphine milligram equivalents (MME) over the first 24-hour post-operative period
Periodo de tiempo: Post-operative day 1 (24 hours after surgery)
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Cumulative opioid consumption will be measured using morphine milligram equivalents (MME) which will convert all administered opioids regardless of agent or route of administration to an equivalent amount of oral morphine using standard conversion factors. Opioid dosage data will be abstracted from the electronic medical record. The total MME administered within the first 24 hours after surgery will be recorded. A lower cumulative MME indicates less opioid requirements. |
Post-operative day 1 (24 hours after surgery)
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Proportion of participants experiencing postoperative nausea or vomiting in the post-anesthesia care unit (PACU)
Periodo de tiempo: PACU arrival to PACU discharge (1-4 hours post-surgery)
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Postoperative nausea or vomiting is defined as any event of nausea or emesis. Episodes will be abstracted from the electronic medical record and corroborated by asking the patient. Events will be recorded during the PACU stay |
PACU arrival to PACU discharge (1-4 hours post-surgery)
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Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 1 (POD1)
Periodo de tiempo: Post-operative day 1 (24 hours after the surgery)
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Postoperative nausea or vomiting is defined as any event of nausea or emesis. Episodes will be abstracted from the electronic medical record and corroborated by asking the patient. Events will be recorded on POD1 |
Post-operative day 1 (24 hours after the surgery)
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Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 3 (POD3)
Periodo de tiempo: Post-operative day 3 (72 hours after the surgery)
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Postoperative nausea or vomiting is defined as any event of nausea or emesis. Episodes will be abstracted from the electronic medical record and corroborated by asking the patient. Events will be recorded on POD3 |
Post-operative day 3 (72 hours after the surgery)
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Proportion of participants who require intra-operative conversion from robotic-assisted surgery to open surgery
Periodo de tiempo: During the surgery (about 60 to 240 minutes)
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Conversion events will be abstracted from the operative note posted on the electronic medical record.
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During the surgery (about 60 to 240 minutes)
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Proportion of participants with clinical or radiographic subcutaneous emphysema
Periodo de tiempo: From start of surgery to PACU discharge (1-4 hours after surgery)
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Cases will be identified by intraoperative inspection of the abdominal wall during the procedure, clinical examination during the PACU stay, and any postoperative imaging that is clinically obtained.
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From start of surgery to PACU discharge (1-4 hours after surgery)
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Proportion of participants who sustained intraoperative pressure elevation (defined as sustained increase to ≥12 mmHg for ≥10 minutes in the AirSeal arm)
Periodo de tiempo: During the surgery (about 60 to 240 minutes)
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Pressure measurements will be obtained from the AirSeal console and elevations will be recorded regardless of reason.
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During the surgery (about 60 to 240 minutes)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cheguevara Afaneh, MD, New York-Presbyterian/Weill Cornell Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-05030301
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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