Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

General Anesthesia Clinical Trial

Official title:

Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267916
• Other study ID #: SMC-2010-12-13
• Status: Completed
• Phase: N/A
• First received: December 28, 2010
• Last updated: January 29, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Seoul Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. The investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Description:

Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It is known that there is a significant negative correlation between PEEPi present and PaO2. Therefore, the investigators postulated that if the reduce the PEEPi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve.

The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA class I or II obesity, Body-mass index > 27.5 undergoing laparoscopic cholecystectomy

Exclusion Criteria:

• patients with severe cardiopulmonary disease peak inspiratory pressure > 40 in the study setting

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• General Anesthesia
• Laparoscopic Cholecystectomy
• Positive-Pressure Respiration, Intrinsic

Intervention

Device:
• RR 6 + 0
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
• RR 10 + 0
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
• RR 16 + 0
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
• RR 6 + 5
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
• RR 10 + 5
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
• RR 16 + 5
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5

Locations

Country	Name	City	State
Korea, Republic of	Seoul Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gas change parameters	PaO2 and PaCO2 the result of arterial blood gas analysis	15 minute interval	No
Secondary	intrinsic positive end-expiratory pressure	PEEPi measured by expiratory port occlusion method	every 15 minutes	No