The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients

NCT02961920 | Completed Results DMC

• 1 other identifier: PrIspSp
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The area of aesthesia-induced atelectasis is much larger in the obese compared with the non-obese, but there may also be more airway closure and impaired matching of ventilation and lung blood flow. When an anesthetized patient is turned to the prone position, dynamic compliance (Cdyn) decreases and peak airway pressure increases unless the abdomen hangs freely to prevent the abdominal viscera from compromising the diaphragm movement. Although the Wilson frame is designed to allow the abdomen to hang, it partially compresses the anterior abdominal wall and therefore does not allow the abdomen to hang completely, especially in obese patients. This in turn increases peak airway pressure and decreases Cdyn, oxygenation. This study aimed to investigate the effects of a prolonged I:E ratio (i.e., 1:1) compared with the conventional I:E ratio of 1:2 on respiratory mechanics and hemodynamics during spine surgery in the prone position in obese patients. We hypothesized that, compared with an I:E ratio of 1:2, a ratio of 1:1 improve oxygenation without hemodynamic instability .

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• PaO2(Partial Pressure of Oxygen in Arterial Blood)

  ten minutes after tracheal intubation to 90 min after prone position

  ten minutes after tracheal intubation to 90 min after prone position

Study Arms (2)

IE ratio 1:1

EXPERIMENTAL

Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Device: IE ratio 1:1

IE ratio 1:2

ACTIVE COMPARATOR

Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Device: IE ratio 1:2

Interventions

IE ratio 1:1 DEVICE

Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Also known as: one and one

IE ratio 1:1

IE ratio 1:2 DEVICE

Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Also known as: one and two

IE ratio 1:2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II adult patients scheduled for spine surgery under general anesthesia.
• patient age : greater than 20 years and less than 65years
• Body Mass Index(BMI) \>25 kg/m2

You may not qualify if:

• Patients who have severe pulmonary disease:
• history of chronic obstructive pulmonary disease (COPD), asthma, or pneumothorax. Patients with haemodynamic instability, hypovolaemia, bronchopleural fistula, history of cardiopulmonary disease, or previous lung surgery are excluded.

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

Kyung Cheon Lee

Incheon, 22241, South Korea

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Junju Choi
• Organization: Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University

jjchoi2@gilhospital.com

82324603624

Study Officials

• Kyung Cheon Lee, MD

  Gachon University Gil Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 5, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)