Mechanical Ventilation of Obese Patients During Oral Surgical Procedures

NCT ID: NCT03144609

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-08-31

Brief 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.

Detailed Description

Oral surgeries of obese patients in general endotracheal anesthesia are a special challenge as in the most extensive types of interventions any form of regional anesthesia is inadequate, duration of surgery is short but requires deep level of anesthesia after which a quick awakening and most rapid release from hospital are expected, with a known high perioperative risk complications of obese patients.

Oral surgical procedures in the oral cavity due to possible postoperative upper airway oedema increase the risk of postoperative hypoxia in obese patients. Therefore, it is important to intraoperatively mechanically ventilate obese patients with the aim of good ventilation-perfusion ratio without creating new atelectasis, to minimize the risk of postoperative respiratory decompensation and to provide rapid recovery.

As the prevalence of obesity in the world increases as chronic diseases, the number of obese patients scheduled for oral surgery is growing. Studies involving different ways of intraoperative mechanical ventilation of obese patients are mostly processed laparoscopic abdominal studies that can not exclude the additional effect of intraabdominal pressure on the formation of pulmonary atelectasis.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PEEP 4

Active Comparator low PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with Positive endexpiratory pressure (PEEP) 4 cm H2O(water)

Group Type: ACTIVE_COMPARATOR

low PEEP

Intervention Type: PROCEDURE

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.

PEEP 7 & ARM

Experimental ARM \& Experimental high PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with PEEP( positive endexpiratory pressure) 7 cm H2O with ARM(alveolar recruitment maneuver) provided every 30 min

Group Type: EXPERIMENTAL

ARM

Intervention Type: PROCEDURE

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.

high PEEP

Intervention Type: PROCEDURE

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.

PEEP 10 & ARM

Experimental ARM \& Experimental high PEEP:obese patient during oral-surgical procedures under general anesthesia ventilated with PEEP( positive endexpiratory pressure) 10 cm H2O with ARM(alveolar recruitment maneuver) provided every 30 min

Group Type: EXPERIMENTAL

ARM

Intervention Type: PROCEDURE

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.

high PEEP

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

low positive endexpiratory pressure; alveolar recruitment maneuver; high positive endexpiratory pressure

Eligibility Criteria

Inclusion Criteria

• body mass index greater than 30 kg / m2
• surgical operation in the area of the oral cavity in general endotracheal anesthesia - cystectomy, alveotomy, mandible and maxilla osteosynthesis after jaw trauma, operation of retained and affected teeth, orthodontic surgical treatment of jaw deformity, benign tumor surgery
• ASA (American Society of Anesthesiologists) Classification of Patients 2-3
• duration of general endotracheal anesthesia from 1 to 2.5 hours

Exclusion Criteria

• Allergy to anesthetics
• previous lung operations
• documented heart disease (NYHA II, III)
• Pulmonary disease (asthma, COPD)
• Obstructive pulmonary function disorders according to spirometry: FVC(forced vital capacity) may and may not be normal, FEV1(forced expiratory volume at one second) <80%, FEV1 / FVC <80%)
• neuromuscular disease
• clinical sign of cardiovascular disease established during preoperative treatment
• pregnancy
• Patients who, for some reason after surgery, have to remain intubated and mechanically ventilated in the Intensive Medicine Unit
• refuse to sign informed consent

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klarić, Vlasta, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Klarić, Vlasta, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vlasta Klarić, M.D.

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

vllastica

Identifier Type: -

Identifier Source: org_study_id