Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

NCT01474850 | Completed

• 1 other identifier: Uppsala 2011 - 190
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Ventilation

Keywords

mechanical ventilation; pressure control ventilation; lung recruitment; positive end expiratory pressure; opto-electronic plethysmography; chest wall volume variation; intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Functional residual capacity (FRC)

  5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery

• Oxygenation (paO2)

  5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation

Study Arms (2)

open lung

ACTIVE COMPARATOR

The lung recruitment maneuver (RM) immediately after intubation using pressure controlled ventilation, increase in peak inspiratory pressure up to 30 cm H2O during tidal ventilation, respiratory rate 4/min and positive end expiratory pressure (PEEP) 15 cm H20. PEEP 7 cm H2O until extubation. Inspiratory oxygen concentration (FiO2) 40% during recovery from anesthesia.

Procedure: lung recruitment maneuver

control

NO INTERVENTION

No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.

Interventions

lung recruitment maneuver PROCEDURE

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

open lung

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• ASA classification I-II, scheduled for elective surgery requiring general anesthesia
• signed informed consent

You may not qualify if:

• BMI \> 35
• co-existing respiratory disease (COPD, asthma )
• patient refusal
• pregnancy
• deformities of the thorax

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Uppsala University Hospital, Anesthesia and Intensive care dep.

Uppsala, Uppsala County, 751 85, Sweden

Location

Study Officials

• Peter Frykholm

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff anesthesiologist

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

SE (1)