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

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia (Other)
Overall Status
Completed
CT.gov ID
NCT02912819
Collaborator
INCLIVA (Industry)
30
1
7
4.3

Study Details

Study Description

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 Phase
  • 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)

Study Design

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 :
Jan 1, 2016
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Outcome Measures

Primary Outcome Measures

  1. open-lung condition [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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Sep 23, 2016
Last Update Posted:
Sep 23, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes

Study Results

No Results Posted as of Sep 23, 2016