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

NCT04627883 | Completed DMC

• 1 other identifier: 2020-718
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

inverse ratio ventilation; safe apnea time

Outcome Measures

Primary Outcomes (1)

• Safe Apnea Time

  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% .

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

Secondary Outcomes (3)

• EtO2

  After 3 minutes of preoxygenation After 5 minutes of noninvasive positive pressure ventilation

• EtO2

  After 3 minutes of noninvasive positive pressure ventilation

• EtO2

  After 5 minutes of noninvasive positive pressure ventilation

Study Arms (2)

Group 1:2

OTHER

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

Group 2:1

OTHER

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

Interventions

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.

Group 1:2

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.

Group 2:1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (2)

General Hospital of Ningxia Medical University

General Hospital of Ningxia Medical University, Ningxia, 750004, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: November 13, 2020
• Study Start: August 17, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 17, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)