A Comparison of Different Ventilation Strategies in Infants Using the PLMA™

NCT03235817 | Completed Results FDA Device

• 1 other identifier: IRB00011814
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in infants under general anesthesia. Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated (improved breathing) with the help of the breathing machine versus breathing on their own.

Conditions

Ventilation

Keywords

Proseal™ LMA; infants; ventilation; general anesthesia; outpatient surgery

Outcome Measures

Primary Outcomes (3)

• Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

  Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).

  Up to 45 minutes

• Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups

  Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.

  Up to 45 minutes

• Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups

  Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups

  up to 45 minutes

Secondary Outcomes (3)

• Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.

  Up to 45 minutes

• Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.

  Up to 45 minutes

• Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.

  Up to 45 minutes

Study Arms (3)

Spontaneous ventilation

EXPERIMENTAL

Other: Spontaneous ventilation

Pressure support ventilation

EXPERIMENTAL

Device: Pressure support ventilation

Pressure control ventilation

ACTIVE COMPARATOR

Device: Pressure control ventilation

Interventions

Spontaneous ventilation OTHER

The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.

Spontaneous ventilation

Pressure support ventilation DEVICE

The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.

Pressure support ventilation

Pressure control ventilation DEVICE

The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.

Pressure control ventilation

Eligibility Criteria

• Age: 1 Month - 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA (American Society of Anesthesiologists) physical classification of 1 or 2
• Outpatient surgical procedures
• Surgical procedure anticipated to be \< 90 minutes
• Subject age of 1 - 11 months (inclusive)

You may not qualify if:

• Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
• ASA physical classification of 3, 4 or E
• Premature infants or infants \< 44 weeks post-conceptual age
• Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
• Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
• Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Brain AI, McGhee TD, McAteer EJ, Thomas A, Abu-Saad MA, Bushman JA. The laryngeal mask airway. Development and preliminary trials of a new type of airway. Anaesthesia. 1985 Apr;40(4):356-61.

  PMID: 4003736 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: T. Wesley Templeton, MD
• Organization: Anesthesiology

ttemplet@wakehealth.edu

336-716-4498

Study Officials

• Thomas Templeton, M.D.

  Wake Forest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: August 1, 2017
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 18, 2022
• Results First Posted: January 16, 2018

Record last verified: 2018-04

Locations

US (1)