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Effects of Recruitment Maneuver During Intraoperative Period

Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04239547
Enrollment
80
Registered
2020-01-27
Start date
2019-11-01
Completion date
2020-08-01
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Hysterectomy

Keywords

recruitment, pulmonary complication, oxygenisation

Brief 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.

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.

Interventions

PROCEDUREAlveolar Recruitment maneuver (ARM) +PEEP

Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP

PROCEDUREPEEP

Following anesthesia induction and intubation, only 5 mmHg PEEP

Sponsors

Balikesir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The investigator, the participant and outcomes assessor will be masked to the intervention. Only the caregiver will be aware of the group and intervention received.

Intervention model description

Group 1, Alveolar Recruitment Maneuver+positive end expiratory pressure (PEEP) Group 2, PEEP

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* American Society of Anesthesiology (ASA) I-II * \> 18 y * laparoscopic hysterectomy patients

Exclusion criteria

* 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 * Intracranial tm * Hemodynamic instability * Shock. * Neuromuscular disease

Design outcomes

Primary

MeasureTime frameDescription
measurement of change in airway complianceT1:1minute(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 extubationthe 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 resistanceT1:1 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 extubationthe 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)T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflationArterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.

Secondary

MeasureTime frameDescription
Evaluation of Postoperative respiratory distress, cough, phlegmT9: 24 hours after surgery . T10: on postoperative day 5Pulmonary complications including respiratory distress, cough, phlegm will be evaluated by questionnaire and recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026