Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

Mechanical Ventilation Clinical Trial

Official title:

Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography (OEP).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474850
• Other study ID #: Uppsala 2011 - 190
• Status: Completed
• Phase: N/A
• First received: November 8, 2011
• Last updated: December 5, 2014
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2014
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.

Description:

This is prospective, randomized clinical trial in subjects undergoing elective surgery requiring general anesthesia.

Opto-electronic plethysmography (OEP) has been developed as a non-invasive method for the analysis of chest wall motion, allowing highly accurate measurements of chest wall volume changes of different respiratory compartments in various conditions.

The investigators set out to use this technology to study chest wall volume changes during recovery from total intravenous anesthesia (from discontinuing the anesthetic agent till extubation) and early postoperative period.

The study protocol compares two different approaches:

1. The group receiving recruitment maneuver (RM) immediately after intubation and positive end expiratory pressure (PEEP) 7 cm H20 until extubation. Inspiratory oxygen concentration 40% during recovery from anesthesia.

2. The group not receiving RM, PEEP 0 cm H2O and inspiratory oxygen concentration 100% during recovery from anesthesia.

The volume changes of the chest wall is monitored continuously by OEP, functional residual capacity (FRC) and arterial oxygenation are measured at the defined points in the protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age > 18 years

• ASA classification I-II, scheduled for elective surgery requiring general anesthesia

• signed informed consent

Exclusion Criteria:

• BMI > 35

• co-existing respiratory disease (COPD, asthma )

• patient refusal

• pregnancy

• deformities of the thorax

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• lung recruitment maneuver
RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital, Anesthesia and Intensive care dep.	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Politecnico di Milano

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opto-electronic plethysmography (OEP)	Respiratory movements and thoracic and abdominal volume changes is recorded continuously using OEP (OEP system, BTS,Milan, Italy) by analysing the movements of retro-reflective markers using six video cameras connected to an automatic optoelectronic motion analyser.	1. 5 min after each of these steps: the onset of the mechanical ventilation, the randomization, the end of the surgery 2. continuously during recovery 3. one hour after extubation	No
Secondary	Functional residual capacity (FRC)		5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery	No
Secondary	Oxygenation (paO2)	Arterial blood gas measurement.	5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation	No