Laparoscopic HysterectomyNCT04239547
Effects of Recruitment Maneuver During Intraoperative Period
A study testing Alveolar Recruitment maneuver (ARM) +PEEP and PEEP in people with Laparoscopic Hysterectomy, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Alveolar Recruitment maneuver (ARM) +PEEP and PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Aug 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) I-II
- > 18 y
- laparoscopic hysterectomy patients
Who cannot join
- Patient refusal to participate in the study
- <18 y, BMI> 40
- Patients receiving invasive MV support in the last 1 month
- Patients who received chemotherapy or radiotherapy in the last 2 months
- Patients with severe pulmonary disease (COPD, asthma, pulm infection, bronchiectasis) (those who have previously received Non-Invasive MV, oxygen therapy or steroid therapy for an acute attack)
- Those with known severe pulmonary Hypertension
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- Intracranial tm
- Hemodynamic instability
- Shock.
- Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies
The aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy.
Read the detailed description
In patients over 18 years who are scheduled for laparoscopic hysterectomy volunteering to participate in our study will receive anesthesia induction with one of our standard general anesthesia protocols. After intubation recruitment maneuver will be applied to the study group. General anesthesia and mechanical ventilation will be continued and completed according to our standard practice without any further intervention. Throughout the intraoperative period respiratory and haemodynamic parameters including compliance, airway resistance, mean arterial pressure, heart rate, pulse oxymetry, blood gas analysis, the applied inhalational anesthetic agent, minimum alveolar concentration, expiratory agent concentration and total agent consumption will be recorded. At the end of the operation anesthesia will be terminated and patients will be transferred to postanesthesia care unit (recovery unit after recovery and further discharged from to the ward when their Aldrete score is >8. The patients will be examined for respiratory complications on postoperative day 1, and will be followed up by telephone on day 5.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Alveolar Recruitment maneuver (ARM) +PEEP, PEEP
- Keywords
- recruitment, pulmonary complication, oxygenisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Recruitment maneuver (ARM) +PEEPProcedure or surgery
Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP
PEEPProcedure or surgery
Following anesthesia induction and intubation, only 5 mmHg PEEP
| Study group | Role | What they receive |
|---|---|---|
| Recruitment | Experimental | Patients classified to receive recruitment maneuver + 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation. Receives: Procedure: Alveolar Recruitment maneuver (ARM) +PEEP |
| Non-recruitment | Experimental | Patients classified to receive only 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation. Receives: Procedure: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of change in airway compliance
the patients airway compliance will be monitorised as milliliter / centimeter of water (mL/cmH2O) continuously by the anesthesia machine and will be recorded intermittently.
Measured: T1:1minute(min)after intubationT2:5 min after Mechanical Ventilation(MV),T3:5 min after pneumoperitoneum,T4:3 min after Trendelenburg position(TP),T5:10 min after TP T6:20 min after TP T7:10 min after pneumoperitoneum deflation T8:1 min before extubation
measurement of change in Airway resistance
the patients airway compliance will be monitorised as centimeter of water/ liter/ minute (cmH2O/L/min) continuously by the anesthesia machine and will be recorded intermittently.
Measured: T1:1 minute after intubationT2:5 min after MV T3:5 minute after pneumoperitoneum T4:3 minute after Trendelenburg position (TP) T5:10 minutes after TP T6:20 minutes after TP T7:10 minutes after pneumoperitoneum deflation T8:1 minute before extubation
measurement of change in partial oxygen pressure (PaO2)
Arterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.
Measured: T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation
Secondary outcomes (1)
Evaluation of Postoperative respiratory distress, cough, phlegm
Pulmonary complications including respiratory distress, cough, phlegm will be evaluated by questionnaire and recorded.
Measured: T9: 24 hours after surgery . T10: on postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Nov 2019
- Primary completion1 May 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1, Alveolar Recruitment Maneuver+positive end expiratory pressure (PEEP) Group 2, PEEP
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sagir, MD, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239547
- Sponsor's protocol ID
- osagir-4
- Status last verified
- Nov 2020
- First submitted
- 16 Jan 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies
- ClinicalTrials.gov ID
- NCT04239547
- Acronym / sponsor ID
- osagir-4
- Conditions
- Laparoscopic Hysterectomy
- Keywords
- recruitment, pulmonary complication, oxygenisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 27 Jan 2020 (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 aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy.
Detailed description
In patients over 18 years who are scheduled for laparoscopic hysterectomy volunteering to participate in our study will receive anesthesia induction with one of our standard general anesthesia protocols. After intubation recruitment maneuver will be applied to the study group. General anesthesia and mechanical ventilation will be continued and completed according to our standard practice without any further intervention. Throughout the intraoperative period respiratory and haemodynamic parameters including compliance, airway resistance, mean arterial pressure, heart rate, pulse oxymetry, blood gas analysis, the applied inhalational anesthetic agent, minimum alveolar concentration, expiratory agent concentration and total agent consumption will be recorded. At the end of the operation anesthesia will be terminated and patients will be transferred to postanesthesia care unit (recovery unit after recovery and further discharged from to the ward when their Aldrete score is >8. The patients will be examined for respiratory complications on postoperative day 1, and will be followed up by telephone on day 5.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1, Alveolar Recruitment Maneuver+positive end expiratory pressure (PEEP) Group 2, PEEP
| Arm | Type | Receives |
|---|---|---|
| Recruitment | Experimental | Procedure: Alveolar Recruitment maneuver (ARM) +PEEPPatients classified to receive recruitment maneuver + 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation. |
| Non-recruitment | Experimental | Procedure: PEEPPatients classified to receive only 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) I-II
- > 18 y
- laparoscopic hysterectomy patients
Key exclusion criteria (10 listed)
- Patient refusal to participate in the study
- <18 y, BMI> 40
- Patients receiving invasive MV support in the last 1 month
- Patients who received chemotherapy or radiotherapy in the last 2 months
- Patients with severe pulmonary disease (COPD, asthma, pulm infection, bronchiectasis) (those who have previously received Non-Invasive MV, oxygen therapy or steroid therapy for an acute attack)
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 |
|---|---|---|
| Alveolar Recruitment maneuver (ARM) +PEEPFollowing anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP | Procedure or surgery | Recruitment |
| PEEPFollowing anesthesia induction and intubation, only 5 mmHg PEEP | Procedure or surgery | Non-recruitment |
Primary outcome
measurement of change in airway compliance
Time frame: T1:1minute(min)after intubationT2:5 min after Mechanical Ventilation(MV),T3:5 min after pneumoperitoneum,T4:3 min after Trendelenburg position(TP),T5:10 min after TP T6:20 min after TP T7:10 min after pneumoperitoneum deflation T8:1 min before extubation
the patients airway compliance will be monitorised as milliliter / centimeter of water (mL/cmH2O) continuously by the anesthesia machine and will be recorded intermittently.
measurement of change in Airway resistance
Time frame: T1:1 minute after intubationT2:5 min after MV T3:5 minute after pneumoperitoneum T4:3 minute after Trendelenburg position (TP) T5:10 minutes after TP T6:20 minutes after TP T7:10 minutes after pneumoperitoneum deflation T8:1 minute before extubation
the patients airway compliance will be monitorised as centimeter of water/ liter/ minute (cmH2O/L/min) continuously by the anesthesia machine and will be recorded intermittently.
measurement of change in partial oxygen pressure (PaO2)
Time frame: T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation
Arterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.
1 secondary outcome
Evaluation of Postoperative respiratory distress, cough, phlegm
Time frame: T9: 24 hours after surgery . T10: on postoperative day 5
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 17 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Recruitment maneuver (ARM) +PEEP and PEEP in people with Laparoscopic Hysterectomy, run by Balikesir University at 1 site 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 3 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 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?
measurement of change in airway compliance (time frame: T1:1minute(min)after intubationT2:5 min after Mechanical Ventilation(MV),T3:5 min after pneumoperitoneum,T4:3 min after Trendelenburg position(TP),T5:10 min after TP T6:20 min after TP T7:10 min after pneumoperitoneum deflation T8:1 min before extubation). The study lists 3 primary outcomes in all. 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 17 Nov 2020.