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

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04627883
Collaborator
(none)
40
Enrollment
2
Locations
2
Arms
4
Actual Duration (Months)
20
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Inspiratory-to-expiratory (I : E) ratio of 1:2
  • Other: Inspiratory-to-expiratory (I : E) ratio of 2:1
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients:A Randomized Controlled Trial
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1:2

Patients in the control group had noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2.

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

Patients in the IRV group had noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1.

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

Outcome Measures

Primary Outcome Measures

  1. Safe Apnea Time [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 Outcome Measures

  1. EtO2 [After 3 minutes of preoxygenation After 5 minutes of noninvasive positive pressure ventilation]

    Fractional concentration of oxygen in end-tidal gas

  2. EtO2 [After 3 minutes of noninvasive positive pressure ventilation]

    Fractional concentration of oxygen in end-tidal gas

  3. EtO2 [After 5 minutes of noninvasive positive pressure ventilation]

    Fractional concentration of oxygen in end-tidal gas

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital of Ningxia Medical University General Hospital Of Ningxia Medical University Ningxia China 750004
2 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004

Sponsors and Collaborators

  • General Hospital of Ningxia Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:
NCT04627883
Other Study ID Numbers:
  • 2020-718
First Posted:
Nov 13, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by General Hospital of Ningxia Medical University
inverse ratio ventilation
safe apnea time
Additional relevant MeSH terms:
Apnea

Study Results

No Results Posted as of Nov 13, 2020