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Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients

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ClinicalTrials.gov Identifier: NCT02912819
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
INCLIVA
Information provided by (Responsible Party):
Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary:

General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized patients.

Investigators hypothesized that the SpO2 breathing air can personalize the open-lung approach.


Condition or disease Intervention/treatment
Abdominal Cancer Other: Open-lung approach

Detailed Description:
Increase in airway pressure until the SpO2 reaches 97% (lung´s opening pressure) during the incremental positive end-expiratory (PEEP) limb. Decrease in the PEEP level until the SpO2 decreases bellow 97% (lung´s closing pressure)

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Intervention Details:
  • Other: Open-lung approach
    Increase and decrease in airway pressure to open the lung and keep them opened.


Primary Outcome Measures :
  1. open-lung condition [ Time Frame: During the experimental protocol (Intraoperative) ]
    The role of the SpO2 to detect lung´s closing and opening pressures was evaluated by the discrete receiver operating characteristic (ROC) analysis. With PtpEE and PaO2/FIO2 as the reference methods, a binary classification of "1" to the open-lung condition defined as positive PtpEE or PaO2/FIO2 >400 mmHg and "0" presence of lung collapse defined as negative PtpEE or PaO2/FIO2 <400 mmHg. Also, a value of "1" was assigned when the SpO2 was ≥ 97% and a value of "0" when the value was < 97%.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study included all patients with ASA status I-III scheduled for elective abdominal laparoscopic surgery.
Criteria

Inclusion Criteria:

  • Non-obese patients with ASA physical status I-III undergoing elective abdominal laparoscopic surgery with an expected operating time of less than 2 hours were included.

Exclusion Criteria:

  • age of <18 years,
  • preoperative SpO2 ≤97% while breathing room air, and
  • patients with previous known cardiac or respiratory disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912819


Locations
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Spain
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
INCLIVA
Publications:
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Responsible Party: Carlos Ferrando, MD, PhD, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT02912819    
Other Study ID Numbers: SpO2-guide RM
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shared data will be anonymous