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

NCT02912819 | Completed

• 1 other identifier: SpO2-guide RM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• open-lung condition

  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%.

  During the experimental protocol (Intraoperative)

Interventions

Open-lung approach OTHER

Increase and decrease in airway pressure to open the lung and keep them opened.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included all patients with ASA status I-III scheduled for elective abdominal laparoscopic surgery.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• Instituto de Investigacion Sanitaria INCLIVA: collaborator

Study Sites (1)

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

• Tusman G, Groisman I, Fiolo FE, Scandurra A, Arca JM, Krumrick G, Bohm SH, Sipmann FS. Noninvasive monitoring of lung recruitment maneuvers in morbidly obese patients: the role of pulse oximetry and volumetric capnography. Anesth Analg. 2014 Jan;118(1):137-44. doi: 10.1213/01.ane.0000438350.29240.08.

  PMID: 24356163 BACKGROUND

• Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.

  PMID: 24557111 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: September 23, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)