Mechanical Ventilation of Obese Patients During Oral Surgical Procedures

NCT03144609 | Unknown

• 1 other identifier: vllastica
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

mechanical ventilation, obesity, oral-surgical procedures

Outcome Measures

Primary Outcomes (1)

• preoperative and postoperative change in arterial blood gas analysis within and between groups of patients

  preoperative blood gas analysis measured an hour before induction and compared with blood gas analysis measured four times in postoperative period, after three different strategies of mechanical ventilation.Blood gas analysis will be compared within a group and between the groups.

  Preoperative parameters were compared with change in early postoperative parameter. Early postoperative measurements were measurements after 15 minutes from the operation, then in the first and third hours, and 24 hours after the operation.

Secondary Outcomes (4)

• change in preoperative and postoperative degree of dyspnoea measured on Visual Analog Scale

  25 perioperative hours.Preoperative degree was measured one hour before the start of the operation. Early postoperative measurements were measured 15 min after the operation started, then in the first, third and 24th hours after surgery

• The connection between the various risks of difficult intubation and obesity.

  up to 1 day:Visual Scale Cormack- Lehane classification was measured at laryngoscopy for intubation by investigator, all other measurements were measured once at preoperative Anesthetic examination

• PEEP effects on MAP

  1-2,5 intraoperative hours.Intraoperative measurements were performed 5 min before and 5 min after induction, then every 30 minutes during operation.Change in MAP includes only period from the beginning operation to the end of surgery and extubation.

• ARM(alveolar recruitment maneuver) effects on MAP

  1-2,5 intraoperative hours.Intraoperative measurements were performed 5 min before and 5 min after induction, then every 30 min during operation, and 5 min after ARM is performed. Change in MAP includes period from the beginning to the end of operation

Study Arms (3)

PEEP 4

ACTIVE COMPARATOR

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

Procedure: low PEEP

PEEP 7 & ARM

EXPERIMENTAL

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

Procedure: ARM; Procedure: high PEEP

PEEP 10 & ARM

EXPERIMENTAL

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

Procedure: ARM; Procedure: high PEEP

Interventions

low PEEP 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.

Also known as: low positive endexpiratory pressure

PEEP 4

ARM 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.

Also known as: alveolar recruitment maneuver

PEEP 10 & ARM; PEEP 7 & ARM

high PEEP 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.

Also known as: high positive endexpiratory pressure

PEEP 10 & ARM; PEEP 7 & ARM

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klarić, Vlasta, M.D.: lead

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 Officials

• Vlasta Klarić, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 9, 2017
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share