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The effect of Lavandula angustifolia extract on gastric residual volume in mechanically ventilated patients hospitalized in the Intensive Care Units

Protocol summary

Study aim
1.Determining and Comparing the gastric residual volume of mechanically ventilated patients in both the intervention and control groups before and after the administration of lavender extract.
Design
“A clinical trial with a control group, using parallel groups,with no bias involved, randomized, involving 60 patients. Randomization was achieved using permuted blocks of four, written on six cards with six states, and utilizing dice for selection.”
Settings and conduct
“After receiving ethical approval and obtaining a trial code from the Iranian Clinical Trials Center, as well as coordinating with Sabzevar and Gonabad Medical Universities, written consent will be obtained from their legal guardians after sample collection. The study objectives will be explained. Patients will initially be allocated to intervention and control groups through convenience sampling. Families of the participants will be assured that they will not be deprived of routine treatment and that they can withdraw from the study at any stage.”
Participants/Inclusion and exclusion criteria
Inclusion: 1.Stable hemodynamic conditions. 2.Connected to a ventilator. 3.Not pregnant. Exclusion: 1.Patient death.
Intervention groups
“In the intervention group, a dose of 5 milliliters of lavender extract will be administered via gavage at 9, 15, and 21 hours after gavage feeding. For assurance, 40 milliliters of tap water will be administered via gavage. The placebo group will receive 45 milliliters of tap water after gavage. Then, the remaining volume in the patients’ stomachs will be measured 3 and 6 hours after gavage before proceeding to the second phase of receiving the lavender extract. The intervention will be carried out for one week.”
Main outcome variables
Gastric residual volume, Lavender extract, AgeGender,Tobacco use, Bp, Body temperature, Duration of being ventilated

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250222064802N1
Registration date: 2025-03-07, 1403/12/17
Registration timing: prospective

Last update: 2025-03-07, 1403/12/17
Update count: 0
Registration date
2025-03-07, 1403/12/17
Registrant information
Name
Esmail saburie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4421 0369
Email address
saburie72@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Lavandula angustifolia extract on gastric residual volume in mechanically ventilated patients hospitalized in the Intensive Care Units
Public title
The effect of Lavandula angustifolia extract on gastric residual volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients admitted to the intensive care unit (ICU) after 24 hours of their admission 2.Written informed consent from the patient’s legal guardian for participation in the study 3.Age between 18 and 60 years 4.Stable hemodynamic conditions 5.No history of drug addiction to narcotics or strong analgesics based on documentation and questioning of the patient’s legal guardian 6.No sensitivity to lavender extract, as determined by questioning the patient’s legal guardian 7.Being connected to a ventilator 8.Having a nasogastric or orogastric tube 9.Not using prokinetic drugs such as metoclopramide and erythromycin within 8 hours before the intervention 10.No history of recent (10 days or less) stomach or gastrointestinal system ulcers or surgery 11.Not pregnant 12.No history of hypothyroidism, hypoglycemia, or occurrence of paralytic ileus 13.Not using laxatives 14.GCS ≤ 7 (Glasgow Coma Scale score of 7 or less) 15.No history of any digestive diseases.
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
“Initially, eligible patients admitted to intensive care units (ICUs) are selected based on inclusion criteria. Subsequently, they will be randomly assigned to either the control or intervention group using permuted blocks of four. The possible arrangements in a block of four include six states: AABB, BBAA, ABAB, BABA, ABBA, BAAB. These are written on six separate cards, each assigned a number from one to six. Then, using a die, one of the six possible states is selected, and patients are categorized into the intervention and control groups accordingly. This process will continue until the sample size is complete.”
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
No. 122,Shams Abadi Alley 18., Jahad Ave., Sabzevar City., Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619894733
Approval date
2025-02-18, 1403/11/30
Ethics committee reference number
IR.GMU.REC.1403.157

Health conditions studied

1

Description of health condition studied
Diseases of the digestive system
ICD-10 code
K92
ICD-10 code description
Other diseases of digestive system

Primary outcomes

1

Description
1.Residual gastric volume
Timepoint
Measurement of gastric residual volume before the intervention and 3.6 hours after the intervention for one week
Method of measurement
60cc gavage syringe

Secondary outcomes

1

Description
Blood pressure
Timepoint
In each shift and for one week before the intervention
Method of measurement
Electronic blood pressure monitor

2

Description
Pulse
Timepoint
In each shift and for one week before the intervention
Method of measurement
Pulse oximeter device

Intervention groups

1

Description
This comprehensive protocol details the procedures and data collection methods employed in both the control and intervention groups.Data Collection and Monitoring: A standardized checklist will be used for all participants. The checklist comprises four sections: (1) A demographic and clinical information form (7 questions), completed by the patient’s legal guardian; (2) Ventilator settings information (2 questions); (3) Vital signs recording; and (4) Measurement of gastric residual volume (GRV) performed by the research personnel. All patients will receive standard medical and nursing care, tailored to their individual conditions and physician orders, throughout the study.Patient Positioning and GRV Measurement: To mitigate the risk of aspiration, all patients (control and intervention groups) will be positioned semi-recumbent at a 30-45 degree angle. This position will be maintained for one hour after each intervention or procedure. GRV will be measured using aspiration with a 60 ml gavage syringe (Soupa Co.) with the syringe positioned at least 12 inches above the patient’s stomach. Patients with a GRV exceeding 500 ml will be excluded from further participation in the study. Continuous cardiac and respiratory monitoring will be implemented during all gavage procedures, and patients will be closely observed.Nutritional Protocol: After a 24-hour fasting period, both groups will receive enteral nutrition via a nasogastric or orogastric tube (size 16, orange). Feeding will be administered slowly over 10 minutes using a 60 ml gavage syringe. Caloric requirements will be determined by a clinical nutritionist based on the patient’s ideal body weight, ensuring adherence to established nutritional standards. Feeding will commence with a volume of 100-150 ml every three hours, gradually increasing to 250-300 ml per feeding over a week, based on the patient’s tolerance. The same enteral formula will be used for all patients, administered in 6 divided doses over a 24-hour period, every 3 hours, excluding feeding times at 3 AM and 6 AM, in accordance with ICU protocols. The enteral formula will consist of standard Intramil nutritional supplement powder (Hayati Karn Pharmaceutical and Food Supplements Co.) and hospital soup (to standardize the nutrient composition). Medications will not be mixed with the gavage feeds to avoid potential alterations in therapeutic responses.Intervention Group (Lavender Extract): Following feeding, the intervention group will receive 5 ml of lavender extract (Zarband Pharmaceutical Co.) via gavage three times daily, at 9 AM, 3 PM, and 9 PM. Following lavender administration, 40 ml of tap water will be administered via gavage to ensure complete delivery of the medication to the stomach, and the nasogastric/orogastric tube will be clamped.GRV Monitoring and Aspiration Management: To assess the effects of the intervention, gastric residual volume will be measured every 3 and 6 hours post-feeding, prior to the next lavender extract administration. This will be performed by trained research personnel and the results recorded on the checklist. All research personnel involved in measuring GRV will undergo standardized training prior to study commencement to ensure consistency in measurement techniques. If patients require oropharyngeal or endotracheal suctioning and gavage contents are observed in the secretions, indicating potential aspiration, suctioning will be initiated. Aspiration will be identified through continuous patient observation and review of patient charts, and appropriate interventions will be provided. This protocol will be implemented for one week, with all interventions and measurements conducted every six hours. The dependent variables will be measured immediately upon completion of the intervention period.
Category
Treatment - Drugs

2

Description
Control group: Data Collection and Monitoring: A standardized checklist will be used for all participants. The checklist consists of four sections: (1) Demographic and Clinical Information Form (7 questions), completed by the patient’s legal guardian. (2) Ventilator Settings Information (2 questions). (3) Vital Signs Recording. and (4) Gastric Residual Volume (GRV) measurements were performed by research personnel. All patients will receive standard medical and nursing care throughout the study, tailored to their individual circumstances and physician orders.Patient Positioning and GRV Measurement: To reduce the risk of aspiration, all patients (control and intervention groups) will be placed in a semi-recumbent position at a 30-45 degree angle. This position will be maintained for one hour after each intervention or procedure. GRV is measured using aspiration with a 60 ml gavage syringe (Supa Corporation) while the syringe is at least 12 inches above the patient's stomach. Patients with a GRV greater than 500 ml will be excluded from further study participation. Continuous cardiac and respiratory monitoring will be performed throughout the gavage procedure, and patients will be closely monitored.Feeding Protocol: After a 24-hour fasting period, both groups will receive enteral feedings via a nasogastric or gastric tube (size 16, orange). Feedings will be administered slowly over 10 minutes using a 60 ml gavage syringe. Calorie requirements will be determined by a clinical dietitian based on the patient's ideal body weight, ensuring that established nutritional standards are met. Feedings will begin at a volume of 100-150 ml every three hours and will gradually increase to 250-300 ml per feeding over one week, based on patient tolerance. The same enteral formula is used for all patients, administered in 6 divided doses over a 24-hour period, every 3 hours, except for feedings at 3 AM and 6 AM, according to ICU protocols. The enteral formula is composed of standard Intramil nutritional supplement powder (Karen Vital Pharmaceutical and Food Supplements Company) and hospital soup (to standardize the nutrient composition). To avoid possible changes in therapeutic responses, drugs are not mixed with gavage feeds.Control group (lavender extract): After feeding, the placebo group will be given tap water (according to the ward routine where water is given after gavage of food) in a volume of 45 ml at 9,15,21 hours after gavage. The nasogastric/gastric-oral tube is closed.GRV monitoring and aspiration management: To assess the effects of the intervention, gastric residual volume will be measured every 3 and 6 hours after feeding, before the next administration of lavender extract. This will be performed by trained research personnel and the results will be recorded on a checklist. All research personnel involved in GRV measurement will undergo standard training prior to the start of the study to ensure consistency in measurement techniques. Suction will be initiated if patients require oropharyngeal or endotracheal suctioning and gavage contents are seen in the discharge, indicating potential aspiration. Aspiration will be identified through continuous patient observation and review of patient charts, and appropriate interventions will be provided. The protocol will be implemented for one week, with all interventions and measurements performed every six hours. Dependent variables will be measured immediately after the intervention period ends.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Beheshti Sabzevar Hospital
Full name of responsible person
Esmaeil Saburie
Street address
No. 122,Shams Abadi Alley 18., Jahad Ave., Sabzevar City., Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619894373
Phone
+98 51 4421 0369
Email
Saburie72@gmail.com

2

Recruitment center
Name of recruitment center
Bahlul Gonabadi Hospital
Full name of responsible person
Esmaeil Saburie
Street address
No. 122,Shams Abadi Alley 18., Jahad Ave., Sabzevar City., Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9619894373
Phone
+98 51 4421 0369
Email
saburie72@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Firouzi
Street address
Side of the Asian road
City
gonabad
Province
Razavi Khorasan
Postal code
969169996
Phone
+98 51 5722 3028
Email
Research@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Esmaeil Saburie
Position
Nursing Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 122,Shams Abadi Alley 18., Jahad Ave., Sabzevar City., Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619894373
Phone
+98 51 4421 0369
Email
saburie72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Esmaeil Saburie
Position
Nursing Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 122,Shams Abadi Alley 18., Jahad Ave., Sabzevar City., Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619894373
Phone
+98 51 4421 0369
Email
saburie72@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Esmaeil Saburie
Position
Nursing Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 122,Shams Abadi Alley 18., Jahad Ave., Sabzevar City., Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619894373
Phone
+98 51 4421 0369
Email
saburie72@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to the results of the study except the personal information of the subject
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
All people working in the Ministry of Health and researchers and professors and students working in academic institutions and ordinary people
Under which criteria data/document could be used
Access data and documents by referring to the article and mentioning the source of the article
From where data/document is obtainable
To the researchers of the desired study and respected professors of the study in the form of communication channels mentioned in the study
What processes are involved for a request to access data/document
send email
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