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Mechanical Ventilation of Obese Patients During Oral Surgical Procedures

NCT03144609 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2017-05-09

No results posted yet for this study

Summary

The prevalence of obese patients in a great number of patients scheduled for elective surgery under general anesthesia has been on the increase. Recent studies suggest an intraoperative protective mechanical ventilation for the obese. Surgical procedures in the oral cavity increase the risk of perioperative complications of obese patients. By making this randomized clinical study, investigators want to determine whether the protective intraoperative ventilation with the use of higher positive end-expiratory pressure and recruitment maneuvers compared to ventilation with low positive end-expiratory pressure and without recruitments cause better postoperative respiratory function parameters of obese patients during oral surgical procedures. Investigators also aim to establish the fact which value of a positive end-expiratory pressure has a favorable impact on the respiratory function without negative hemodynamic effect.

Conditions

Interventions

PROCEDURE

low PEEP

The control group consisted of obese patients mechanically ventilated by a standardized volume-controlled breathing mode with low respiratory volume without alveolar recruitment maneuver and using low values of PEEP up to 4 cm H2O.

PROCEDURE

ARM

The experimental groups also consisted of obese patients mechanically ventilated by a volume-controlled breathing mode with low respiratory volume 7 ml/kg ideal body mass, but with alveolar recruitment maneuver performed immediately after induction, followed every 30 minutes during the hemodynamic stable condition under operation.

PROCEDURE

high PEEP

The experimental groups also consisted of obese patients mechanically ventilated by a volume-controlled breathing mode with low respiratory volume 7 ml/kg ideal body mass, but with higher PEEP, provided that the upper limit of 40 cm H20 was not exceeded.

Sponsors & Collaborators

  • Klarić, Vlasta, M.D.

    lead INDIV

Principal Investigators

  • Vlasta Klarić, M.D.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-30
Completion
2017-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144609 on ClinicalTrials.gov