NCT05033353

Brief Summary

During (OLV) in (VATS) ; many physiological factors may increase risk of hypoxemia such as positioning and intrapulmonary shunt thus compromising cerebral blood flow and oxygenation, resulting in postoperative neurocognitive dysfunctions. The authors hypothesized that increasing (EtCO2) is the most convenient and powerful method for the management of cerebral desaturation. Methods: Seventy patients undergoing VATS were enrolled in this randomized controlled trial. Mechanical ventilation was adjusted to maintain an EtCO2 of 33-38 mm Hg in group I and an EtCO2 of 39-45 mm Hg in group II. Regional cerebral oxygenation was monitored using near-infrared spectroscopy (O3TM, Masimo, Irvine, CA) placed on the patient's forehead.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

August 23, 2021

Last Update Submit

January 11, 2022

Conditions

Thoracic Diseases

Keywords

OLV

Outcome Measures

Primary Outcomes (3)

  • Effect of changing end tidal CO2 on the regional cerebral oxygen saturation %

    Intraoperative ventilatory parameters will be adjusted to attain two different end tidal CO2 and the effect on the regional cerebral oxygen saturation % detected

    5 months

  • Heart rate

    Intraoperative heart rate (beat per minute) monitoring allover the surgery

    5 months

  • Blood pressure

    Intraoperative blood pressure (mmHg) monitoring allover the surgery

    5 months

Secondary Outcomes (1)

  • Postoperative cognitive function

    5 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

Mechanical ventilation was adjusted to maintain an EtCO2 of 33-38 mm Hg in group I regional cerebral oxygen monitoring

Diagnostic Test: Monitoring of regional cerebral oxygenation

Group II

ACTIVE COMPARATOR

Mechanical ventilation was adjusted to maintain an EtCO2 of 39-45 mm Hg in group II regional cerebral oxygen monitoring

Diagnostic Test: Monitoring of regional cerebral oxygenation

Interventions

Monitoring of regional cerebral oxygenationDIAGNOSTIC_TEST

Regional cerebral oxygenation was monitored using near-infrared spectroscopy (O3TM, Masimo, Irvine, CA) placed on the patient's forehead.

Group IGroup II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18-65 years old
  • Patients withASA I and II
  • Patients with body mass index (BMI) 21-29 kg/m2
  • Patients with admitted for elective VATS requiring OLV for about 1-1.5 h

You may not qualify if:

  • Patients with severe bronchial asthma
  • Patients with chronic obstructive pulmonary disease
  • Patients with severe renal insufficiency
  • Patients with severe liver dysfunction
  • Patients with cerebrovascular disease
  • Patients with coagulopathy, uncontrolled diabetes mellitus
  • Patients with uncontrolled hypertension
  • Patients with cardiovascular disease
  • Patients with mental disabilities
  • Patients with hearing impairment were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mohamed Mogahed

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Mona M Mogahed

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Randomization was done by sealed envelope method and the patients were divided into two groups; group I (targeted EtCO2 32-38 mmHg) and group II (targeted EtCO2 39-45 mmHg). only the anesthetist knows the group of the patient
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 2, 2021

Study Start

September 2, 2021

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

January 12, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)