Different Preoxygenation Methods In Cesarean Section | NCT05395975

Studies
Different Preoxygenation Methods In Cesarean Section

NCT05395975

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

May 27, 2022Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Hypoxia
Hyperoxia

Interventions

Oxygen Reserve Index

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Dec 27, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

May 12, 2022

First Submission Date that Met QC Criteria

May 24, 2022

First Posted Date

May 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2022

Last Update Posted Date

May 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and 4 deep breaths) in pregnant women with oxygen reserve index (ORI).

After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45, different preoxygenation methods will be applied, and the oxygen status of the patients will be compared with ORI monitoring.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		Preoxygenation with 100% oxygen for 3 minutes	Device: Oxygen Reserve Index
Group II		4 deep breaths with 100% oxygen in 30 seconds	Device: Oxygen Reserve Index

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen Reserve Index	Device	It is a new non-invasive and continuous measurement parameter that aims to provide information about the oxygen status of patients in the moderately hyperoxic range (100 mmHg< PaO2 ≤ 200 mmHg).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preoxygenation Methods	Effects of Different Preoxygenation Methods on SaO2, FiO2 and FeO2 with Oxygen Reserve Index	During the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The average operation time is 30 minutes-1.5 hours.
ASA II risk class
All pregnant women with a gestational week >36

Exclusion Criteria:

preeclampsia
eclampsia
fetal distress
morbid obesity
a history of malignant hyperthermia
opioid sensitivity
alcohol or drug addiction
congestive heart failure
chronic obstructive pulmonary disease
coronary artery disease
anemia, liver and kidney disease
hypovolemia, hypotension, sepsis
Those who are allergic to the drugs used in the study and who are suspected of difficult intubation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Patients aged 18-45 who had cesarean section under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University Faculty of Medicine		Zonguldak	Kozlu	67600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia
D018496	Hyperoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided