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

Completed

• Conditions: Abdominal Cancer

• Registration Number: NCT02912819
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-09
• Study First Submitted: 2016-09-11
• Study First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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%.

Trial Locations

Locations (1)

Department of Anesthesia and Critical Care; Hospital Clinico Universitario; 🇪🇸 Valencia, Spain