ObesityNCT03144609
Mechanical Ventilation of Obese Patients During Oral Surgical Procedures
A study testing low PEEP, ARM and high PEEP in people with Obesity, run by Klarić, Vlasta, M.D..
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- low PEEP, ARM and high PEEP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Impact of Protective Mechanical Ventilation of Obese Patients on the Postoperative Respiratory Function During Oral Surgical Procedures
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.
Read the 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
- Being tested
- low PEEP, ARM, high PEEP
- Keywords
- mechanical ventilation, obesity, oral-surgical procedures
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low PEEPProcedure or surgery
Also called low positive endexpiratory pressure
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.
ARMProcedure or surgery
Also called alveolar recruitment maneuver
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 PEEPProcedure or surgery
Also called high positive endexpiratory pressure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 Receives: Procedure: ARM; Procedure: high PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
the degree of dyspnea in the early postoperative period between and within groups and compared with preoperative status. The degree of dyspnoea was determined by the participants on the Visual Analog Scale (0-10). Change From Baseline in dyspnoea Scores on the Visual Analog Scale at 24 hours were measured.
Measured: 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.
morphological characteristics of oral cavity of obese patients,as indicators of the risk of severe intubation, such as interdental spacing in open mouth, type of bite, Mallampati Classification , Cormack-Lehane classification, thyromental and sterno-mental distance and anatomical anomaly of the face . Compare their association with impaired ventilation and / or intubation according to body mass index through study completion
Measured: 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
intraoperative effect of different PEEP values on systemic circulatory stability by measuring systolic and diastolic blood pressure and mean arterial blood pressure (MAP).
Measured: 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
intraoperative effect of lung recruitment maneuvers on systemic circulatory stability by measuring systolic and diastolic blood pressure and mean arterial blood pressure (MAP).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startNov 2015
- Primary completionApr 2017
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klarić, Vlasta, M.D.
- Responsible party
- Principal investigator, Klarić, Vlasta, M.D., Klarić, Vlasta, M.D.
- Investigators
- Vlasta Klarić, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144609
- Sponsor's protocol ID
- vllastica
- Status last verified
- May 2017
- First submitted
- 27 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protective Mechanical Ventilation of Obese Patients on the Postoperative Respiratory Function During Oral Surgical Procedures
- ClinicalTrials.gov ID
- NCT03144609
- Acronym / sponsor ID
- vllastica
- Conditions
- Obesity
- Keywords
- mechanical ventilation, obesity, oral-surgical procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Klarić, Vlasta, M.D.
- Study start
- Nov 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEP 4 | Active comparator | Procedure: low PEEPActive Comparator low PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with Positive endexpiratory pressure (PEEP) 4 cm H2O(water) |
| PEEP 7 & ARM | Experimental | Procedure: ARM, Procedure: high PEEPExperimental 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 |
| PEEP 10 & ARM | Experimental | Procedure: ARM, Procedure: high PEEPExperimental 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low PEEPAlso: low positive endexpiratory pressureThe 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 or surgery | PEEP 4 |
| ARMAlso: alveolar recruitment maneuverThe 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 or surgery | PEEP 10 & ARM, PEEP 7 & ARM |
| high PEEPAlso: high positive endexpiratory pressureThe 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. | Procedure or surgery | PEEP 10 & ARM, PEEP 7 & ARM |
Primary outcome
preoperative and postoperative change in arterial blood gas analysis within and between groups of patients
Time frame: 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.
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.
4 secondary outcomes
change in preoperative and postoperative degree of dyspnoea measured on Visual Analog Scale
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlasta Klarić, M.D. principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing low PEEP, ARM and high PEEP in people with Obesity, run by Klarić, Vlasta, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative and postoperative change in arterial blood gas analysis within and between groups of patients (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.