NCT04591327

Brief Summary

In this study aimed to demonstrate that atelectasis developing in the perioperative period of patients undergoing elective cesarean surgery with spinal or general anesthesia methods using lung ultrasound. After Preoperative lung ultrasounds of patients is done, the cesarean operation will be completed with spinal or general anesthesia. In the postoperative period, control lung ultrasounds will be performed and the ultrasound results will be compared in terms of atelectasis in both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 4, 2020

Last Update Submit

October 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of the postoperative atelectasis

    two months

Study Arms (2)

general anesthesia

Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections

spinal anesthesia

Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections

Interventions

Preoperative lung ultrasound will be performed on all patients and baseline values will be recorded. The sensory block level under T10 of the patients who underwent spinal anesthesia in the postoperative period lung ultrasonography will be done after regression. In the postoperative period, lung ultrasonography will be performed in patients undergoing spinal anesthesia when the sensory block level is below T10. In the general anesthesia group, when the neuromuscular block is completely reversed and the Aldrete score is\> 9, lung ultrasonography will be performed. The degree of atelectasis will be determined according to the modified LUS score.

general anesthesiaspinal anesthesia

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Between 18-40 years old, 37-40 weeks pregnant, ASA II because of pregnancy.

You may qualify if:

  • Between 18-40 years
  • weeks pregnant
  • ASA II because of pregnancy

You may not qualify if:

  • Emergency cesarean sections
  • who refuse to participate in the study
  • with chronic disease
  • Smoker
  • with chest deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Derince Train and Research Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

October 4, 2020

First Posted

October 19, 2020

Study Start

August 1, 2020

Primary Completion

September 14, 2020

Study Completion

September 16, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations