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Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics

NCT ID: NCT03352375

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-10-31

Brief Summary

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The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.

Detailed Description

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Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.

Conditions

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Pediatric Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All pediatric patients, who were scheduled to undergo laparoscopic surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orotracheally Intubation

Intervention:orotracheally intubation

Group Type ACTIVE_COMPARATOR

Orotracheally intubation

Intervention Type DEVICE

Interventions used for airway safety and ventilation during surgical procedures

Laryngeal Mask Airway

Intervention: Laryngeal Mask Airway

Group Type ACTIVE_COMPARATOR

Laryngeal Mask Airway

Intervention Type DEVICE

Interventions used for airway safety and ventilation during surgical procedures

Interventions

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Orotracheally intubation

Interventions used for airway safety and ventilation during surgical procedures

Intervention Type DEVICE

Laryngeal Mask Airway

Interventions used for airway safety and ventilation during surgical procedures

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia.

Exclusion Criteria

* Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Canan Tulay ISIL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Canan Tulay Isil, MD

Role: PRINCIPAL_INVESTIGATOR

Sisli Hamidiye Etfal Training and Research Hospital

References

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Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth. 2007 Apr;17(4):327-32. doi: 10.1111/j.1460-9592.2006.02127.x.

Reference Type BACKGROUND
PMID: 17359400 (View on PubMed)

Other Identifiers

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SEEAH 462/17.03.2015

Identifier Type: -

Identifier Source: org_study_id