NCT04698863

Brief Summary

To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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

April 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 4, 2021

Last Update Submit

January 8, 2021

Conditions

Hyperoxia

Keywords

General anesthesiaOxygen reserve indexOxygenationHyperoxia

Outcome Measures

Primary Outcomes (1)

  • to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia.

    to assess oxygenation with the oxygen reserve index (ORI) in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.

    During the surgery procedure

Study Arms (2)

high flow rate

After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 4 L/min for Group High flow rate.

Device: Oxygen reserve index

low flow rate

After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 1 L/min for Group Low flow rate.

Device: Oxygen reserve index

Interventions

Oxygen reserve indexDEVICE

eveluating oxygen reserve in blood

high flow ratelow flow rate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Aged between 18-65 years undergoing tympanomastoidectomy surgery

You may qualify if:

  • American Society of Anesthesiologists (ASA) risk class I-II,
  • Undergoing tympanomastoidectomy

You may not qualify if:

  • Morbid obesity
  • Opioid sensitivity Alcohol or drug addiction
  • Chronic obstructive pulmonary disease
  • Coronary artery disease,
  • Congestive heart failure
  • Pronounced anemia
  • Have a history of liver or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 7, 2021

Study Start

April 1, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)