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

Abdominal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912819
• Other study ID #: SpO2-guide RM
• Status: Completed
• Phase: N/A
• First received: September 11, 2016
• Last updated: September 21, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Cancer

Intervention

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

Locations

Country	Name	City	State
Spain	Department of Anesthesia and Critical Care; Hospital Clinico Universitario	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	INCLIVA Clinical Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No