NCT04106869

Brief Summary

This prospective study is designed to examine the influence of intra-operative ventilation on perioperative neurocognitive disorders in patients undergoing total hip arthroplasty.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

September 25, 2019

Last Update Submit

May 8, 2023

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

  • T-MOCA-baseline

    In order to evaluate perioperative neurocognitive disorders, patients will take the T-MOCA test

    12 hours

  • T-MOCA-6-weeks-postoperatively

    In order to evaluate perioperative neurocognitive disorders, patients will take the T-MOCA test

    6 weeks

  • T-MOCA-3-months-postoperatively

    In order to evaluate perioperative neurocognitive disorders, patients will take the T-MOCA test

    3 months

Secondary Outcomes (3)

  • Concentration of patient's baseline pre-operative peripheral IL-6

    12 hours

  • Concentration of patient's post-operative peripheral IL-6; 6 hours post-operative

    24 hours

  • Concentration of patient's post-operative peripheral IL-6 ; 24 hours post-operative

    24 hours

Study Arms (2)

Hyperventilation

ACTIVE COMPARATOR

Ventilatory settings will be the following: 6-8 ml/kg and Respiratory rate adjusted to the required ETC02 (\<35 mmHg) PEEP in order to ensure a driving pressure (P plateau- PEEP) below 15 mmHg.

Other: Hyperventilation

Hypoventilation

PLACEBO COMPARATOR

Ventilatory settings will be the following: 6-8 ml/kg and Respiratory rate adjusted to the required ETC02 ( 40-45 mmHg) PEEP in order to ensure a driving pressure (P plateau- PEEP) below 15 mmHg.

Other: Hypoventilation

Interventions

HyperventilationOTHER

Ventilatory settings will be the following: 6-8 ml/kg and Respiratory rate adjusted to the required ETC02 (\<35 mmHg) PEEP in order to ensure a driving pressure (P plateau- PEEP) below 15 mmHg.

Hyperventilation
HypoventilationOTHER

Ventilatory settings will be the following: 6-8 ml/kg and Respiratory rate adjusted to the required ETC02 (40-45 mmHg) PEEP in order to ensure a driving pressure (P plateau- PEEP) below 15 mmHg.

Hypoventilation

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with an ASA (American Society of Anesthesia) score of I- III
  • Scheduled for total hip arthroplasty

You may not qualify if:

  • lack of local language comprehension
  • neuropsychiatric disturbance
  • history of drug/alcohol abuse
  • use of anticholinergic drugs, benzodiazepines, opiates/neuroleptic drugs
  • patients with an infectious disease within the last month/immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine) or chronic medication with potential immune-modulatory effects
  • patients who underwent major surgery within the last 3 months
  • Patients with cardiovascular, or respiratory diseases (including smoking) resulting in clinically relevant impaired function
  • Patients with pre-existing CVA, dementia, and other neurological conditions that would interfere with their ability to participate cognitively
  • patients with active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU-Charleroi Hopital Civil Marie Curie

Charleroi, Hainaut, Belgium

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Sarah Saxena, MD

    CHU Charleroi

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patients will be blinded to the group, as well as the outcomes assessor and the investigator. The anesthesiologist responsible for the patient's anesthesia will not be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

November 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)