The Effect of Ventilation Modes on Cerebral Oxymetry In Operation

NCT04723043 | Completed

• 1 other identifier: 1305
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.

Conditions

Cholecystitis; Gallstone; Mechanical Ventilation Pressure High; Intraabdominal Hypertension

Keywords

laparoscopy

Outcome Measures

Primary Outcomes (3)

• NIRS

  near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation

  0 to 3 hours (approximately)

• oxygen saturation

  oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation

  0 to 3 hours (approximately)

• end-tidal carbon dioxide

  end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation

  0 to 3 hours (approximately)

Secondary Outcomes (2)

• partial oxygen pressure

  0 to 3 hours (approximately)

• P peak

  0 to 3 hours (approximately)

Study Arms (2)

v group

ACTIVE COMPARATOR

patients will ventilate with volume controlled mode

Device: mechanical ventilation modes

p group

ACTIVE COMPARATOR

patients will ventilate with pressure controlled mode

Device: mechanical ventilation modes

Interventions

mechanical ventilation modes DEVICE

ventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery

p group; v group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anesthesiology) score of 1 and 2
• body mass index \< 30 kg/m2
• planned elective laparoscopic cholecystectomy operation
• years old

You may not qualify if:

• who are applied with emergency laparoscopic cholecystectomy operation
• ASA (American Society of Anesthesiology) score of 3 and above
• hematocrit value 30 and below
• body mass index\> 30 kg/m2
• major pulmonary disease (this condition was defined as having capacity and currency flow speed values that are below %70 in respiratory functional tests)
• patients with a history of thoracic surgery

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Etfal Research and Training Hospital

Şişli, Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

• Gipson CL, Johnson GA, Fisher R, Stewart A, Giles G, Johnson JO, Tobias JD. Changes in cerebral oximetry during peritoneal insufflation for laparoscopic procedures. J Minim Access Surg. 2006 Jun;2(2):67-72. doi: 10.4103/0972-9941.26651.

  PMID: 21170237 BACKGROUND

• Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.

  PMID: 16115985 BACKGROUND

• Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.

  PMID: 24672486 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Gallstones; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ayse surhan cinar

  chief of anesthesia department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist medical doctor

Model Details: The first group was labelled as "Group V" as they are applied with mechanical ventilation under controlled volume, and the second group was labelled as "Group P" as they are applied with mechanical

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 25, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)