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OpenTrials
Completed

NCT Number: NCT02912819

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

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.

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Key information

Conditions

Abdominal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Valencia, 46010, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open-lung approach

Other

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

Primary outcomes

  1. open-lung condition

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Instituto de Investigacion Sanitaria INCLIVA

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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