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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02912819
Enrollment
30
Registered
2016-09-23
Start date
2016-01-31
Completion date
2016-08-31
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Cancer

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)

Interventions

OTHEROpen-lung approach

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

Sponsors

Instituto de Investigacion Sanitaria INCLIVA
CollaboratorOTHER
Fundación para la Investigación del Hospital Clínico de Valencia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
open-lung conditionDuring 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%.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026