AnesthesiaNCT04208737
Effects of Recruitment Maneuver on Functional Residual Capacity
A study testing recruitment maneuver in people with Anesthesia and Surgery, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Surgery, Atelectasis
- What is being tested?
- recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 Dec 2019to 1 Jun 2020
- 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
- 1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery
Who cannot join
- <18 years old
- >65 years old
- denial of patient
- patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University
Istanbul, 34069
Istanbul University, Department of Anesthesiology
Istanbul, 34093
About this study
Official title: Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.
Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units.
The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.
Read the detailed description
An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with TIVA.
FRC will be measured in different steps of the operation. In the study group, a recruitment manover will be applied to evaluate its effects on FRC.
- Conditions
- Anesthesia, Surgery, Atelectasis
- Being tested
- recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment maneuverProcedure or surgery
30 cmH2O pressure 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation After the operation,Postoperative Room Air Test (RAT) will be applied. |
| study group | Experimental | 5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds .
First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation
First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation Receives: Procedure: recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of FRC measurements at beginning and end of anesthesia
First FRC will be measured after ; the last FRC will be measure bedore the extubation
Measured: within max 5 minutes after the intubation and with max 5 minutes before the extubation
Secondary outcomes (1)
Positive room air test
in recovery room when patient modified aldrete score ≥ 9 patient SPO2 when breathing in room air If patients' spo2 value ≤ 96%, named as room air test positive
Measured: in recovery room 30 minutes after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start23 Dec 2019
- Primary completion1 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuzhet Mert Senturk, MD, Prof, Istanbul University
- Investigators
- Elif Aygun, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208737
- Sponsor's protocol ID
- 2018/938
- Status last verified
- Jun 2020
- First submitted
- 16 Dec 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT04208737
- Acronym / sponsor ID
- 2018/938
- Conditions
- Anesthesia, Surgery, Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 23 Dec 2019 (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.
Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units.
The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.
Detailed description
An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with TIVA.
FRC will be measured in different steps of the operation. In the study group, a recruitment manover will be applied to evaluate its effects on FRC.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation After the operation,Postoperative Room Air Test (RAT) will be applied. |
| study group | Experimental | Procedure: recruitment maneuver5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds . First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery
Key exclusion criteria (4 listed)
- <18 years old
- >65 years old
- denial of patient
- patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
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 |
|---|---|---|
| recruitment maneuver30 cmH2O pressure 15 seconds | Procedure or surgery | study group |
Primary outcome
Comparison of FRC measurements at beginning and end of anesthesia
Time frame: within max 5 minutes after the intubation and with max 5 minutes before the extubation
First FRC will be measured after ; the last FRC will be measure bedore the extubation
1 secondary outcome
Positive room air test
Time frame: in recovery room 30 minutes after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- 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.
Elif Aygun, MD principal investigator
Istanbul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recruitment maneuver in people with Anesthesia and Surgery, run by Istanbul University at 2 sites in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of FRC measurements at beginning and end of anesthesia (time frame: within max 5 minutes after the intubation and with max 5 minutes before the extubation). 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 Jun 2020.