- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282003
Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications
February 20, 2024 updated by: Masa Kontic
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maša Kontić, Medical Doctor; a
- Phone Number: 00385 98 97 95 648
- Email: mkontic.konti@gmail.com
Study Contact Backup
- Name: General hospital Zabok Veterans'hospital Zabok, anaesthesiology
- Phone Number: 00385 49 294 290
- Email: ambulanta.anestezija@bolnica-zabok.hr
Study Locations
-
-
-
Zabok, Croatia, 49210
- Recruiting
- General hospital Zabok
-
Contact:
- Maša Kontić, Medical Doctor
- Phone Number: 00385 98 97 95 648
- Email: mkontic.konti@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- ASA 4 status
- terminal renal illness
- cardiac status NYHA III i NYHA IV
- at home oxygenotherapy during 16 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional ventilation procedure
|
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.
|
Experimental: The protective lung ventilation procedure
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygentation
Time Frame: 10 months
|
The primary outcome was the incidence of early preoperative pulmonary complications (within the first 5 postoperative days).
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Estimated)
February 28, 2024
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 380-59-10106-21-111/148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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