NCT05509764

Brief Summary

In pregnancy, cephalal shift of the diaphragm caused by the enlarged uterus reduces the functional residual capacity and may increase the closure volume and predispose the pregnant woman to airway closure, leading to atelectasis. The development of atelectasis due to dermatomes retained in spinal anesthesia and intraoperative supine position may increase further. Oxygen therapy to be applied may also lead to absorption atelectasis by causing hyperoxia. The aim of our study is to evaluate the effect of oxygen support on the lungs in cesarean section operations under spinal anesthesia by lung ultrasound score and oxygen reserve index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

May 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

August 18, 2022

Last Update Submit

August 22, 2022

Conditions

Keywords

Atelectasislung ultrasoundoxygen reserve indexcesarean section

Outcome Measures

Primary Outcomes (1)

  • atelectasis

    measuring atelectasis due to oxygen therapy

    during the surgery

Secondary Outcomes (2)

  • APGAR score

    1st and 5th min after delivery

  • hypotension

    during surgery

Study Arms (3)

group 0

control group

Diagnostic Test: lung ultrasound score

group 3

3 Lt/min Oxygen therapy via nasal cannula

Diagnostic Test: lung ultrasound score

group 6

6 Lt/min Oxygen therapy via Simple face mask

Diagnostic Test: lung ultrasound score

Interventions

lung ultrasound scoreDIAGNOSTIC_TEST

determination of atelectasis by lung ultrasound score

group 0group 3group 6

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparturients who underwent cesarean section under spinal anesthesia
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

parturients who underwent cesarean section under spinal anesthesia

You may qualify if:

  • years old
  • ASA I-II
  • Patients scheduled for elective cesarean section under spinal anesthesia

You may not qualify if:

  • alcohol or drug addiction, chronic obstructive pulmonary disease, cardiovascular disease, smokers anemia, liver or kidney disease, coagulation disorders allergic to anesthetic agents, sepsis or bacterial infection, body temperature is below 35°C and above 38°C Multiple pregnancy Preoperative hypoxemia SpO2\<94% Diabetes mellitus Hypertension Placenta previa Premature rupture of membranes Intrauterine growth retardation Preeclampsia-eclampsia-fetal distress Polyhydramnios Morbid obesity BMI\>45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manolya Alkan

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary AtelectasisHypotension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 22, 2022

Study Start

May 1, 2021

Primary Completion

March 1, 2022

Study Completion

August 1, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Locations