Well-Being, PsychologicalNCT06282003
Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications
A study testing The procedure of protective lung ventilation in people with Well-Being, Psychological, run by Masa Kontic at 1 site in Croatia.
Trial summary
Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- The procedure of protective lung ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Oct 2023to 30 Sep 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the inclusion criteria were as follows:
- subject status according to the American Society of Anesthesiologists Association classification
- ASA 1 (normal healthy patients, i.e. patients without associated comorbidities) or ASA 2 (patients with mild systemic disease, such as well-controlled hypertension), normal heart and lung function, both sexes,
- non-smokers, normal X-ray findings for heart and lungs,
- age 18-65 years,
- planned operation of medial laparotomy for colorectal cancer with a minimum duration of anesthesia of at least one hour,
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- signed informed consent.
- In the case of hypertension in ASA 2 patients enrolled in the study, by examining the self-monitoring diary for the past three months (as described in Gropper et al., 2019), there was no increase in systolic pressure more than 20 mmHg from the average daily value and no increase in diastolic arterial pressure more than 10 mmHg from the average daily value.
- In the case of diabetes type II in ASA 2 patients enrolled in the study, the HbA1c values were not higher than 7% while taking oral hypoglycemic drugs and having a regulated diet. The patients enrolled also had no complications or episodes of hypoglycemia in the past three months, as described by Gropper et al., 2019.
- In the case of thyroid disease in ASA 2 patients enrolled in the study, values of TSH, fT3, and fT4 in the period up to 6 months since the last examination were normal.
Who cannot join
- ASA 4 status
- terminal renal illness
- cardiac status NYHA III i NYHA IV
- at home oxygenotherapy during 16 hours
Trial locations and contacts
1 site in 1 country.
General hospital Zabok Veterans'hospital Zabok, anaesthesiology contact
Croatia1 site, 1 recruiting
- Recruiting
General hospital Zabok
Zabok, 49210
Maša Kontić, Medical Doctor, 00385 98 97 95 648, mkontic.konti@gmail.com
About this study
Official title: Protective Lung Ventilation Procedure During General Anesthesia Reduces the Incidence of Pulmonary Complications After Abdominal Surgery, Possibly
Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia.
Read the detailed description
Additionally, despite accumulated knowledge and careful monitoring, sometimes an anesthesiologist is still unable to entirely avoid the occurrence of atelectasis, a common phenomenon observed during general anesthesia. Altogether, it can be concluded that the effects of mechanical ventilation and oxygenation over an extended period are not yet well understood, particularly regarding the impact of reducing tidal volume and using higher PEEPs. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia.
- Conditions
- Well-Being, Psychological
- Being tested
- The procedure of protective lung ventilation
- Keywords
- general anaesthesia, intraoperative complications, postoperative complications, lung recruitment procedure therapeutic positive-pressure ventilation
- Medical subject headings
- Psychological Well-Being, Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The procedure of protective lung ventilationProcedure or surgery
The procedure of protective lung ventilation in the PV group of patients included preoxygenation with 60% oxygen in a mixture with air for 3 min, which maintained the target peripheral oxygen saturation at values above 94%, endotracheal intubation, volume-controlled mechanical ventilation, a tidal volume of 6 ml per kg of body weight. Normocarbia during the protective ventilation procedure was maintained by adjusting the minute ventilation, which is the product of the respiratory rate (12-14 breaths per minute) and the tidal volume set to 6 ml/kg of body weight. The most critical variable for the adjustment was the inhalation-exhalation ratio of 1:2, which ensured adequate oxygenation and removal of carbon dioxide during anesthesia. Identically as in the PV group, the target peripheral saturation was kept above 94% with an inspiratory oxygen concentration of 50% and peak airway pressure values of up to 40 kPa.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ventilation procedure | Active comparator | Not described Receives: Procedure: The procedure of protective lung ventilation |
| The protective lung ventilation procedure | Experimental | In the PV group, laung protective ventilation also included the procedure of opening the alveoli (recruitment maneuver, RM). RM was performed twice. The first instance occurred following the administration of anesthesia, with a FiO2 value of 50% (0.5). The second instance took place shortly before extubation. RM consisted of maintaining an airway pressure of 40-45 kPa for 40 s, which keeps the collapsed alveoli open and corresponds to maximum spontaneous inhalation. The specified pressure of PEEP during RM refers to conditions where hemodynamic stability. PEEP was set at 7 kPa, but just before the extubation and awakening, patients were switched to spontaneous breathing the PEEP was set to 10 kPa. There was no additive effect of positive pressure, just an addition of 3 kPa positive airway pressure was applied to keep current alveoli open continuously and possibly recruit some new ones in that short period, which corresponds to the stochastic model of respiration. Receives: Procedure: The procedure of protective lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygentation
The primary outcome was the incidence of early preoperative pulmonary complications (within the first 5 postoperative days).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start10 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- Crossover
- Model description
- A crossover design should be utilized in addition to the randomization procedure to properly address outcome variability. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masa Kontic
- Sponsor type
- Other government
- Collaborators
- Prof.Dinko Tonković, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb, Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar, Prof. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb, Prof. Anamarija Jazbec, Faculty of Forestry and Wood Technology, University of Zagreb, Marijan Jedvaj, MD Anesthesiologist and ICU physician (Consultant), Head of Department of Anesthesia and IC, General Hospital Zabok
- Responsible party
- Sponsor-investigator, Masa Kontic, Croatian Health Insurance Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282003
- Sponsor's protocol ID
- 380-59-10106-21-111/148
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Lung Ventilation Procedure During General Anesthesia Reduces the Incidence of Pulmonary Complications After Abdominal Surgery, Possibly
- ClinicalTrials.gov ID
- NCT06282003
- Acronym / sponsor ID
- 380-59-10106-21-111/148
- Conditions
- Well-Being, Psychological
- Keywords
- general anaesthesia, intraoperative complications, postoperative complications, lung recruitment procedure therapeutic positive-pressure ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Masa KonticOther government
- Collaborators
- Prof.Dinko Tonković, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb, Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar, Prof. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb, Prof. Anamarija Jazbec, Faculty of Forestry and Wood Technology, University of Zagreb, Marijan Jedvaj, MD Anesthesiologist and ICU physician (Consultant), Head of Department of Anesthesia and IC, General Hospital Zabok
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia.
Detailed description
Additionally, despite accumulated knowledge and careful monitoring, sometimes an anesthesiologist is still unable to entirely avoid the occurrence of atelectasis, a common phenomenon observed during general anesthesia. Altogether, it can be concluded that the effects of mechanical ventilation and oxygenation over an extended period are not yet well understood, particularly regarding the impact of reducing tidal volume and using higher PEEPs. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A crossover design should be utilized in addition to the randomization procedure to properly address outcome variability. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Conventional ventilation procedure | Active comparator | Procedure: The procedure of protective lung ventilation |
| The protective lung ventilation procedure | Experimental | Procedure: The procedure of protective lung ventilationIn the PV group, laung protective ventilation also included the procedure of opening the alveoli (recruitment maneuver, RM). RM was performed twice. The first instance occurred following the administration of anesthesia, with a FiO2 value of 50% (0.5). The second instance took place shortly before extubation. RM consisted of maintaining an airway pressure of 40-45 kPa for 40 s, which keeps the collapsed alveoli open and corresponds to maximum spontaneous inhalation. The specified pressure of PEEP during RM refers to conditions where hemodynamic stability. PEEP was set at 7 kPa, but just before the extubation and awakening, patients were switched to spontaneous breathing the PEEP was set to 10 kPa. There was no additive effect of positive pressure, just an addition of 3 kPa positive airway pressure was applied to keep current alveoli open continuously and possibly recruit some new ones in that short period, which corresponds to the stochastic model of respiration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- the inclusion criteria were as follows:
- subject status according to the American Society of Anesthesiologists Association classification
- ASA 1 (normal healthy patients, i.e. patients without associated comorbidities) or ASA 2 (patients with mild systemic disease, such as well-controlled hypertension), normal heart and lung function, both sexes,
- non-smokers, normal X-ray findings for heart and lungs,
- age 18-65 years,
Key exclusion criteria (4 listed)
- ASA 4 status
- terminal renal illness
- cardiac status NYHA III i NYHA IV
- at home oxygenotherapy during 16 hours
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 |
|---|---|---|
| The procedure of protective lung ventilationThe procedure of protective lung ventilation in the PV group of patients included preoxygenation with 60% oxygen in a mixture with air for 3 min, which maintained the target peripheral oxygen saturation at values above 94%, endotracheal intubation, volume-controlled mechanical ventilation, a tidal volume of 6 ml per kg of body weight. Normocarbia during the protective ventilation procedure was maintained by adjusting the minute ventilation, which is the product of the respiratory rate (12-14 breaths per minute) and the tidal volume set to 6 ml/kg of body weight. The most critical variable for the adjustment was the inhalation-exhalation ratio of 1:2, which ensured adequate oxygenation and removal of carbon dioxide during anesthesia. Identically as in the PV group, the target peripheral saturation was kept above 94% with an inspiratory oxygen concentration of 50% and peak airway pressure values of up to 40 kPa. | Procedure or surgery | Conventional ventilation procedure, The protective lung ventilation procedure |
Primary outcome
Oxygentation
Time frame: 10 months
The primary outcome was the incidence of early preoperative pulmonary complications (within the first 5 postoperative days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
General hospital Zabok Veterans'hospital Zabok, anaesthesiology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The procedure of protective lung ventilation in people with Well-Being, Psychological, run by Masa Kontic at 1 site in Croatia.
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 10 inclusion and 4 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Maša Kontić, Medical Doctor; a (00385 98 97 95 648, mkontic.konti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygentation (time frame: 10 months). 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 28 Feb 2024.