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

NCT03330067 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-27

No results posted yet for this study

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.

Conditions

  • Pneumoperitoneum

Interventions

DEVICE

Cold and dry CO2 pneumoperitoneum

In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.

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.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Richard Whelan, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-09-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330067 on ClinicalTrials.gov