Effect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™

NCT03390127 | Completed

• 1 other identifier: 2017-1397
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to compare the effect of PEEP on arterial oxygen partial pressure in elderly patients undergoing urologic surgery using LMA supreme™ in a lithotomy position.

Conditions

Urinary Bladder Neoplasms; Prostatic Neoplasms

Keywords

elderly; lithotomy position; PEEP; laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• The difference of arterial oxygen partial pressure (PaO2) between group P and group Z

  The difference of arterial oxygen partial pressure (PaO2) between group P and group Z 1 hour after LMA insertion by arterial blood gas analysis

  1 hour after LMA insertion

Secondary Outcomes (3)

• Postoperative pulmonary complications

  Up to seven days

• Complications associated with LMA

  1 hour after end of surgery

• Incidence of significant leak of LMA

  At 5, 30, 60 mins after LMA insertion

Study Arms (2)

Group P

EXPERIMENTAL

After LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation.

Other: PEEP

Group Z

NO INTERVENTION

After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation.

Interventions

PEEP OTHER

After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.

Also known as: Application of PEEP 7 cmH2O

Group P

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing urologic surgery with lithotomy position under general anesthesia
• Elderly patients (65 ≤ Age \< 80)
• American Society of Anesthesiologists (ASA) physical status: 1-3
• Patients who voluntarily agreed to participate in this clinical study

You may not qualify if:

• Heart failure (ejection fraction ≤ 40%)
• Hemodynamic instability during perioperative period
• Lung diseases (chronic obstructive pulmonary disease, asthma, bullae, pleural effusion)
• Obesity (BMI ≥ 30 kg/m2)
• Neck or upper respiratory tract pathologies
• An increased risk of pulmonary aspiration
• Anticipation of the difficult laryngeal mask fixation due to poor dentition

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Study Officials

• Young-Kug Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 4, 2018
• Study Start: January 5, 2018
• Primary Completion: March 14, 2018
• Study Completion: March 21, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

KR (1)