NCT02267031

Brief Summary

Abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. However, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

October 2, 2014

Last Update Submit

September 21, 2016

Conditions

Response to HyperoxiaHypocapnia

Keywords

cognitive dysfunctionmechanical ventilationhyperoxiahypocapnia

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)

    36 hrs

Secondary Outcomes (3)

  • Psychological Changes

    6 months

  • Pain perception

    6 hrs

  • Pain perception

    36 hrs

Study Arms (4)

normoxia and normocapnia

ACTIVE COMPARATOR

Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg

Procedure: mechanical ventilation

hyperoxia and normocapnia

ACTIVE COMPARATOR

Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg

Procedure: mechanical ventilation

normoxia and hypocapnia

ACTIVE COMPARATOR

Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg

Procedure: mechanical ventilation

hyperoxia-hypocapnia

ACTIVE COMPARATOR

Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg

Procedure: mechanical ventilation

Interventions

mechanical ventilationPROCEDURE

Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2). Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.

hyperoxia and normocapniahyperoxia-hypocapnianormoxia and hypocapnianormoxia and normocapnia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Age \> 18 years and below 80 yrs
  • Elective abdominal endoscopic intervention

You may not qualify if:

  • Known cerebral disorder, incl. traumatic injury and severe vascular impairment
  • Known psychiatric illness
  • Severe drug or alcohol abuse
  • Resent stroke (during last 6 months)
  • Pregnancy
  • Within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ALI. Patients must not participate in such studies for at least 30 days after enrolment into this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

Location

MeSH Terms

Conditions

HypocapniaCognitive DysfunctionHyperoxia

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Mikhail Y. Kirov, MD, PhD

    Northern State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 17, 2014

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

RU(1)