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NCT Number: NCT04627883

Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients

The purpose of this study is to investigate the clinical application value of inverse ratio ventilation in obese patients during induction of general anesthesia by studying the effect of inverse ratio ventilation on the safe apnea time.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University, Ningxia, China

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About this study

Inverse ratio ventilation(IRV) can produce mean airway pressure(Pmean)similar to external positive end expiratory pressure(Peep) by increasing inspiratory time. Moreover, the increase of Pmean was not accompanied by the further increase of peak airway pressure (Ppeak) and airway plateau pressure (Pplat), while the application of external peep accompanied with the increase of Pplat increased the risk of barotrauma . High level of Peep increased cardiac load and decreased cardiac output. A number of studies have found that the hemodynamic stability of patients can be achieved when IRV regulates the inspiratory / expiratory ratio in an appropriate range (I: E < 2:1). Therefore, the inverse ratio is considered to be superior to Peep in terms of gas exchange and respiratory mechanics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Obese patients, aged 18-65 years, of either gender, ASA grade II-III, body mass index (BMI) > 30 kg / m2, scheduled for general anesthesia under tracheal intubation, signed informed consent.

Exclusion criteria

  • Patients who need rapid sequence induction (RSI); patients with expected difficult airway; severe chronic respiratory diseases, such as tuberculosis, bronchitis, bronchial asthma and COPD; patients with severe cardiovascular diseases, such as severe ischemic heart disease and pulmonary hypertension; patients with severe cerebrovascular diseases, such as cerebral hemorrhage and cerebral infarction; patients with abnormal basal metabolic rate, such as pregnancy, thyrotoxicosis, pheochromocytoma; and severe stomach reflux disease; patients with abnormal hemoglobin and hematocrit.

Treatment and study plan

Inspiratory-to-expiratory (I : E) ratio of 1:2

Other

After preoxygenation and induction of anesthesia, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2 for 5 min before endotracheal intubation.

Inspiratory-to-expiratory (I : E) ratio of 2:1

Other

After preoxygenation and induction of anesthesian, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1 for 5 min before endotracheal intubation.

Primary outcomes

  1. Safe Apnea Time

    Time frame: The arterial saturation as measured by pulse oximetry remained at or above 93% after endotracheal intubation immediately.

    The safe apnea time was defined as that period of time during which the arterial saturation as measured by pulse oximetry remained at or above 93% .

Secondary outcomes

  1. EtO2

    Time frame: After 3 minutes of preoxygenation After 5 minutes of noninvasive positive pressure ventilation

    Fractional concentration of oxygen in end-tidal gas

  2. EtO2

    Time frame: After 3 minutes of noninvasive positive pressure ventilation

    Fractional concentration of oxygen in end-tidal gas

  3. EtO2

    Time frame: After 5 minutes of noninvasive positive pressure ventilation

    Fractional concentration of oxygen in end-tidal gas

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients:A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2020
Registry last updated
Feb 17, 2025

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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