Bariatric Surgery CandidateNCT05960071

Effects of Alveolar Recruitment Strategies on Arterial Oxygenation and Postoperative Inflammatory Response During Laparoscopic Bariatric Surgery: A Randomised Control Trial.

A study testing protective lung strategy with recruitment manoeuvre (RM) - steady PEEP and protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEP in people with Bariatric Surgery Candidate, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bariatric Surgery Candidate
What is being tested?: protective lung strategy with recruitment manoeuvre (RM) - steady PEEP and protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEP
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 5 Nov 2022to 5 Jun 2023
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

American Society of Anaesthesiologists physical Status classification scores of 1-2, scheduled for laparoscopic bariatric procedures

Who cannot join

patients refusal,
history of significant pulmonary disease (obstructive or restrictive),
previous pneumothorax,
significant cardiac dysfunction (arrhythmias ± unstable haemodynamics
left ventricular ejection fraction < 40%)
difficult intubation
significant hepatic or renal impairment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Alexandria University Faculty of Medicin
Alexandria, 21615

Other trials in Egypt

About this study

even though the advancement of ambulatory bariatric surgeries, yet the precise spot of recruitment manoeuvres as a secure and efficient approach to enhance the respiratory efficacy of obese patients is still obscured. Previous research have extensively focused their attention towards alveolar recruitment with various positive end-expiratory pressure (PEEP) levels to alleviate anaesthesia induced pulmonary collapse and enhance arterial oxygenation.

Patients and methods: a prospective randomized study involved 60 adult obese patients (18-65 years), with American Society of Anaesthesiologists physical Status classification 1-2, enrolled in 2 groups; Group S: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery. Group D: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Read the detailed description

Atelectasis arises shortly following onset of anaesthesia even among a healthy volunteer, and is closely correlated to escalation of intrapulmonary hypoxemia and inevitable gas exchange derangement .
sixty adult obese patients (body mass index more than 35 kg/m2), of both sexes, aged from 18-65 years old, with American Society of Anaesthesiologists physical Status classification scores of 1-2, scheduled for laparoscopic bariatric procedures. Exclusion criteria were patients refusal, history of significant pulmonary disease (obstructive or restrictive), previous pneumothorax, significant cardiac dysfunction (arrhythmias ± unstable haemodynamics, left ventricular ejection fraction < 40%), difficult intubation as well as those suffering from significant hepatic or renal impairment. Furthermore, patients developed episodes of hemodynamic instability (like desaturation (Sp02< 90 %) or mean blood pressure (MAP) < 60 mmHg) during recruitment manoeuvre were omitted from the study.
Subjects were randomly assigned -via closed envelopes technique opened immediately before induction- into 2 equal groups (n=30 each) to receive 1 of the following ventilatory regimens:
Group S: patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery.
Group D: patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.
Anaesthesia was induced with lidocaine (1mg/kg) followed by (1.5 - 2 mg/kg) propofol (ideal body weight) and (1-1.5 μg/kg) fentanyl. Endotracheal intubation was accomplished with rocuronium (1mg/kg) and a suitable sized tube (8.0 ID). Anaesthesia was maintained with sevoflurane (1-2 %) with (50 %) oxygen in air. Neuromuscular block was continued with rocuronium boluses monitored by train-of four along with additional doses of opioids given as required to achieve a suitable clinical depth of anaesthesia. Precise fluid replacement was administrated consistent with the standard administration guidelines during anaesthesia.
Patients were ventilated using Datex-Ohmeda Aestiva/5 (Madison, WI) anaesthesia machine, (volume controlled mode) with lung protective strategy using a tidal volume of 6- 8 ml/kg ideal body weight, (5-10 cm H20) PEEP and 50 % O2 in air adjusted to reach Spo2 ≥ 95 %. The respiratory rate was adjusted to keep end - tidal Co2 level between (35 -45 mmHg), and inspiratory to expiratory times at a ratio 1:2.
Measurements

Hemodynamic parameters: HR and MAP.
Respiratory mechanics: Peak airway pressure (Paw-peak) and Plateau pressure (Paw-plat).
Oxygenation parameters: Partial arterial tension of oxygen (PaO2), PaO2/FiO2 ratio and oxygen saturation (SpO2). All the previous measurements were recorded at the following time points: T0 (baseline value on room air), T5 (5 minutes after pneumoperitoneum), T30 (30 minutes after first RM), T6o (60 minutes after first RM), T90 (90 minutes after first RM), TE (20 minutes after the end of surgery on nasal cannula 3 L /min). Additional arterial blood gases analysis was performed in the PACU after 30 mins and 1 hr postoperatively.
Serum interleukins (IL)-6 and (IL)-8, using enzyme-linked immunosorbent assay (ELISA) (Biosource, Biosite, Germany) in (pg/ml) were measured as baseline preoperative value and after 24 hr postoperatively. Validation of methods and degrees of concentrations was done following to the accompanied instructions.
Postoperative pulmonary and non-pulmonary complication - (if any) - were assessed and reported in the PACU.
Other variables like: duration of anaesthesia, duration of surgery, pneumoperitoneum time, number of patients needed vasopressors, length of ICU stay and hospital stay.

Conditions: Bariatric Surgery Candidate
Being tested: protective lung strategy with recruitment manoeuvre (RM) - steady PEEP, protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEP
Keywords: bariatric, atelectasis, alveolar recruitment
Medical subject headings: Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

protective lung strategy with recruitment manoeuvre (RM) - steady PEEPProcedure or surgery
protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery.
protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEPProcedure or surgery
protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Study groups in NCT05960071
Study group	Role	What they receive
Group S	Active comparator	patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2O in between RM till end of surgery. Receives: Procedure: protective lung strategy with recruitment manoeuvre (RM) - steady PEEP
Group D	Active comparator	patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery. Receives: Procedure: protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEP

What is being measured

The primary outcome is the main question the study is designed to answer.

Partial arterial tension of oxygen (PaO2),
Measured: 20 minutes postoperatively
Serum interleukins (IL)-6
Measured: after 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20225 Jun 2023

First posted25 Jul 2023
Study start5 Nov 2022
Primary completion30 Apr 2023
Study completion5 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
More trials run by Alexandria 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 60 adult obese patients (18-65 years), with American Society of Anaesthesiologists physical Status classification 1-2, enrolled in 2 groups; Group S: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery. Group D: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05960071
Sponsor's protocol ID: 0305904
Status last verified: Jun 2023
First submitted: 18 Jul 2023
Last updated: 25 Jul 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bariatric Surgery Candidate trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Alveolar Recruitment Strategies on Arterial Oxygenation and Postoperative Inflammatory Response During Laparoscopic Bariatric Surgery: A Randomised Control Trial.
ClinicalTrials.gov ID: NCT05960071
Acronym / sponsor ID: 0305904
Conditions: Bariatric Surgery Candidate
Keywords: bariatric, atelectasis, alveolar recruitment
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 5 Nov 2022 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 5 Jun 2023 (actual)
First posted: 25 Jul 2023 (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.

Detailed description

Atelectasis arises shortly following onset of anaesthesia even among a healthy volunteer, and is closely correlated to escalation of intrapulmonary hypoxemia and inevitable gas exchange derangement .
sixty adult obese patients (body mass index more than 35 kg/m2), of both sexes, aged from 18-65 years old, with American Society of Anaesthesiologists physical Status classification scores of 1-2, scheduled for laparoscopic bariatric procedures. Exclusion criteria were patients refusal, history of significant pulmonary disease (obstructive or restrictive), previous pneumothorax, significant cardiac dysfunction (arrhythmias ± unstable haemodynamics, left ventricular ejection fraction < 40%), difficult intubation as well as those suffering from significant hepatic or renal impairment. Furthermore, patients developed episodes of hemodynamic instability (like desaturation (Sp02< 90 %) or mean blood pressure (MAP) < 60 mmHg) during recruitment manoeuvre were omitted from the study.
Subjects were randomly assigned -via closed envelopes technique opened immediately before induction- into 2 equal groups (n=30 each) to receive 1 of the following ventilatory regimens:
Group S: patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery.
Group D: patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.
Anaesthesia was induced with lidocaine (1mg/kg) followed by (1.5 - 2 mg/kg) propofol (ideal body weight) and (1-1.5 μg/kg) fentanyl. Endotracheal intubation was accomplished with rocuronium (1mg/kg) and a suitable sized tube (8.0 ID). Anaesthesia was maintained with sevoflurane (1-2 %) with (50 %) oxygen in air. Neuromuscular block was continued with rocuronium boluses monitored by train-of four along with additional doses of opioids given as required to achieve a suitable clinical depth of anaesthesia. Precise fluid replacement was administrated consistent with the standard administration guidelines during anaesthesia.
Patients were ventilated using Datex-Ohmeda Aestiva/5 (Madison, WI) anaesthesia machine, (volume controlled mode) with lung protective strategy using a tidal volume of 6- 8 ml/kg ideal body weight, (5-10 cm H20) PEEP and 50 % O2 in air adjusted to reach Spo2 ≥ 95 %. The respiratory rate was adjusted to keep end - tidal Co2 level between (35 -45 mmHg), and inspiratory to expiratory times at a ratio 1:2.
Measurements

Hemodynamic parameters: HR and MAP.
Respiratory mechanics: Peak airway pressure (Paw-peak) and Plateau pressure (Paw-plat).
Oxygenation parameters: Partial arterial tension of oxygen (PaO2), PaO2/FiO2 ratio and oxygen saturation (SpO2). All the previous measurements were recorded at the following time points: T0 (baseline value on room air), T5 (5 minutes after pneumoperitoneum), T30 (30 minutes after first RM), T6o (60 minutes after first RM), T90 (90 minutes after first RM), TE (20 minutes after the end of surgery on nasal cannula 3 L /min). Additional arterial blood gases analysis was performed in the PACU after 30 mins and 1 hr postoperatively.
Serum interleukins (IL)-6 and (IL)-8, using enzyme-linked immunosorbent assay (ELISA) (Biosource, Biosite, Germany) in (pg/ml) were measured as baseline preoperative value and after 24 hr postoperatively. Validation of methods and degrees of concentrations was done following to the accompanied instructions.
Postoperative pulmonary and non-pulmonary complication - (if any) - were assessed and reported in the PACU.
Other variables like: duration of anaesthesia, duration of surgery, pneumoperitoneum time, number of patients needed vasopressors, length of ICU stay and hospital stay.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: 60 adult obese patients (18-65 years), with American Society of Anaesthesiologists physical Status classification 1-2, enrolled in 2 groups; Group S: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery. Group D: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Arm	Type	Receives
Group S	Active comparator	Procedure: protective lung strategy with recruitment manoeuvre (RM) - steady PEEPpatients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2O in between RM till end of surgery.
Group D	Active comparator	Procedure: protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEPpatients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

American Society of Anaesthesiologists physical Status classification scores of 1-2, scheduled for laparoscopic bariatric procedures

Key exclusion criteria (7 listed)

patients refusal,
history of significant pulmonary disease (obstructive or restrictive),
previous pneumothorax,
significant cardiac dysfunction (arrhythmias ± unstable haemodynamics
left ventricular ejection fraction < 40%)

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
protective lung strategy with recruitment manoeuvre (RM) - steady PEEPprotective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery.	Procedure or surgery	Group S
protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEPprotective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.	Procedure or surgery	Group D

Primary outcome

Partial arterial tension of oxygen (PaO2),
Time frame: 20 minutes postoperatively
Serum interleukins (IL)-6
Time frame: after 24 hours postoperative

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 25 Jul 2023.
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.

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?

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 7 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 25 Jul 2023. 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 Egypt. 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?

Partial arterial tension of oxygen (PaO2), (time frame: 20 minutes postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05960071.

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 25 Jul 2023.