Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics

Can Positive Pressure Ventilation be Provided Through a Laryngeal Mask Airway in Pediatrics During Laparoscopic Inguinal Hernia Repair?

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

Study Overview

• Status: Completed
• Conditions: Anesthesia; Pediatric
• Intervention / Treatment: Device: Orotracheally intubation; Device: Laryngeal Mask Airway

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orotracheally Intubation; Intervention:orotracheally intubation	Device: Orotracheally intubation; Interventions used for airway safety and ventilation during surgical procedures
Active Comparator: Laryngeal Mask Airway; Intervention: Laryngeal Mask Airway	Device: Laryngeal Mask Airway; Interventions used for airway safety and ventilation during surgical procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
end tidal carbon dioxide	A parameter measured during positive pressure ventilation	up to 200 minutes

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: Canan Tulay Isil, MD, Sisli Hamidiye Etfal Training and Research Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SEEAH 462/17.03.2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data can only be shared without patients names

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No