Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy

NCT05992636 | Completed FDA Device

• 1 other identifier: Karadeniz Teknik Üniversitesi
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.

Conditions

Pneumoperitoneum

Keywords

laparoscopic cholecystectomy; Near Infrared Spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

• the relationship between insufflation flow rate and cerebral desaturation (rSO2)

  With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS). The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )

  8 months

Secondary Outcomes (3)

• the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)

  8 months

• the relationship between insufflation flow rate and heart rate value variation (beats per minute)

  8 months

• the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)

  8 months

Study Arms (2)

low insufflation flow (10 lt/min)

Patiens who perform pneumoperitoneum with low insufflation flow (10 lt/min)

Procedure: pneumoperitoneum insufflation (flow) rate

high insufflation flow (40 lt/min)

Patiens who perform pneumoperitoneum with high insufflation flow (40 lt/min)

Procedure: pneumoperitoneum insufflation (flow) rate

Interventions

pneumoperitoneum insufflation (flow) rate PROCEDURE

Patiens who initiate with low insufflation flow (10 lt/min) Patiens who initiate with high insufflation flow (40 lt/min)

high insufflation flow (40 lt/min); low insufflation flow (10 lt/min)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After the approval of the Ethics Committee, a total of 69 (sixty) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients with low insufflation flow (10 lt/min), and 35 (thirty-five) patients in high insufflation flow (40 lt/min) with pneumoperitoneum pressure.

You may qualify if:

• elective laparoscopic cholecystectomy were planned,
• ASA I-III,
• years old

You may not qualify if:

• Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
• Uncontrolled diabetes
• Uncontrolled hypertension
• Coagulopathy,
• Cirrhosis and/or peritonitis,
• Asthma and/or respiratory diseases e.g. COPD,
• Morbid obesity,
• Patients with severe organ failure,
• Emergency cases,
• Cases converted to laparotomic cholecystectomy.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• KIVANÇ ÖNCÜ, M.D.

  Karadeniz Technical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: August 15, 2023
• Study Start: May 19, 2021
• Primary Completion: April 23, 2022
• Study Completion: June 20, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

TU (1)