NCT02314845

Brief Summary

The purpose of this randomized single center study is to determine the individual PEEP value that produces the best possible compromise of lung collapse and lung hyperdistention. Patients submitted to general anesthesia and mechanical ventilation during surgery (laparoscopy and open surgery) will participate. A PEEP titration procedure will be performed and the "optimal PEEP" value will be determined by electrical impedance tomography (EIT). An ultrasound will be used to record each step of the PEEP titration procedure in a sub-sample of patients. A total of 40 patients will be mechanically ventilated using physiological tidal volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5 and will be randomized to one of two groups: "optimal PEEP" or a "low PEEP" (4cmH2O). Lung collapse and mechanics will be monitored by EIT throughout the intraoperative period. After extubation, a lung CT will be performed to evaluate the amount of lung collapse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

November 7, 2014

Last Update Submit

May 10, 2016

Conditions

Pulmonary Atelectasis

Keywords

Pulmonary AtelectasisPulmonary VentilationAnesthesia, GeneralElectric ImpedanceTomography, Spiral ComputedIntraoperative Period

Outcome Measures

Primary Outcomes (1)

  • Optimal PEEP value

    The PEEP value, for each patient, that produces the best possible compromise of lung collapse and lung hyperdistention during a PEEP titration procedure using EIT

    6 minutes

Secondary Outcomes (2)

  • Pulmonary atelectasis

    2-5 hours

  • Ultrasound evaluation

    6 minutes

Study Arms (2)

Optimal PEEP

EXPERIMENTAL

Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure using Electrical Impedance Tomography (EIT). Patients will be mechanically ventilated during intraoperative period using "Optimal PEEP" determined by Electrical Impedance and FIO2 of 0.5.

Other: Optimal PEEP

Low PEEP

OTHER

Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure EIT. In this arm, the ventilator will be set with a PEEP=4 cmH2O ("Low PEEP") and FIO2 of 0.5 during intraoperative period.

Other: Low PEEP

Interventions

Optimal PEEPOTHER

"Optimal PEEP" determined by EIT during a PEEP titration procedure.

Optimal PEEP
Low PEEPOTHER

Use of PEEP of 4 cmH2O during intraoperative period

Low PEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients submitted to general anesthesia for surgical procedure

You may not qualify if:

  • Age \< 18 years
  • Thoracic surgery (any)
  • ASA grade III or IV
  • History of moderate/severe chronic obstructive pulmonary disease (COPD) or moderate/severe Asthma
  • Moderate/severe restrictive lung disease
  • Use of heart pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

  • Tonelotto B, Pereira SM, Tucci MR, Vaz DF, Vieira JE, Malbouisson LM, Gay F, Simoes CM, Carvalho Carmona MJ, Monsel A, Amato MB, Rouby JJ, Costa Auler JO Jr. Intraoperative pulmonary hyperdistention estimated by transthoracic lung ultrasound: A pilot study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):825-831. doi: 10.1016/j.accpm.2020.09.009. Epub 2020 Oct 17.

    PMID: 33080407DERIVED

  • Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.

    PMID: 30260897DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Joaquim E Vieira, MD, PhD

    University of Sao Paulo General 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
Associate Professor, Anesthesiology

Study Record Dates

First Submitted

November 7, 2014

First Posted

December 11, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

BR(1)