Endotracheal tube cuff pressure estimation techniques: safety and reliability among women undergoing general anaesthesia with intubation for cesarean section
| ISRCTN | ISRCTN66168037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66168037 |
| Secondary identifying numbers | UHAS REC A.9[114]20-21 |
- Submission date
- 01/07/2021
- Registration date
- 16/07/2021
- Last edited
- 10/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
An endotracheal tube is a flexible plastic tube that is placed through the mouth into the windpipe (trachea). The use of an endotracheal tube has become routine for women undergoing general anaesthesia for a cesarean section. Its insertion can damage the trachea due to excessive pressure in the cuff. This study aims to compare the techniques involve in cuff inflation and its corresponding pressure estimations as well as associated complications among parturients undergoing general anaesthesia with intubation for cesarean section at the obstetric unit of the Tamale Teaching Hospital.
Who can participate?
Pregnant women aged 18 to 40 undergoing cesarean section under general anaesthesia with intubation
What does the study involve?
An anesthesiologist inflates the endotracheal tube cuff and determines the cuff pressure using either of the following techniques: standard manometer, predetermined volume of air (10 - 15 ml), or manual palpation of the endotracheal tube pilot balloon immediately after intubation. Before extubation, the pressure gauge is used to measure the actual pressure generated using manual palpation of the pilot balloon or the predetermined volume of air (10 - 15 ml).
What are the possible benefits and risks of participating?
The findings of this study will provide information on endotracheal tube cuff pressure procedures and will influence anaesthesia clinical policies, the monitoring of endotracheal tube cuff pressure and its estimation. Cuff pressure associated complications (cough, sore throat, hoarseness, and blood-streaked expectoration) may result.
Where is the study run from?
Tamale Teaching Hospital (Ghana)
When is the study starting and how long is it expected to run for?
December 2020 to November 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Sylvanus Kampo
sylvanuskampo@yahoo.com
Contact information
Scientific
C.K. Tedam University of Technology and Applied Sciences
Navrongo
00233
Ghana
| Phone | +233 (0)559355229 |
|---|---|
| skampo@cktutas.edu.gh |
Scientific
Habana Medical Services
Tamale
+233
Ghana
| Phone | +233 (0)242186766 |
|---|---|
| thomas.anabah@uds.edu.gh |
Study information
| Study design | Prospective randomized comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Endotracheal tube cuff pressure estimation techniques: safety and reliability among parturients undergoing general anaesthesia with intubation for cesarean section at the obstetric unit of the Tamale Teaching Hospital. A prospective randomized comparative study |
| Study objectives | The experience in cuff pressure estimation by the anaesthesia providers correlates poorly within therapeutic limits. The manual palpation of the pilot balloon technique is associated with a high incidence of cough, sore throat, hoarseness, and blood-streaked expectoration among parturients. The standard manometer technique is the ideal and should routinely be used to estimate endotracheal tube cuff pressures among parturients undergoing cesarean section under general anaesthesia |
| Ethics approval(s) | Approved 01/06/2021, the ethical committee of the University of Health and Allied Sciences (PMB 31, Ho Volta Region, Ghana; +233 (0)362196193; rec@uhas.edu.qh), ref: UHAS REC A.9[114]20-21 |
| Health condition(s) or problem(s) studied | Elective cesarean section |
| Intervention | All parturients are prospectively assessed and classified according to the American Society of Anesthesiologists (ASA) physical status classification. Basic intraoperative monitoring (ECG, SpO₂, temperature, and non-invasive blood pressure) is applied, and the baseline vital signs are checked and recorded. The individual parturient is advised not to eat any solid food for at least 6-8 hours before surgery. An independent anesthesiologist is assigned to perform the intubation and monitor the patient till discharge from the hospital. In the supine position, the parturient is anaesthetized with propofol 1.5-2 mg/kg, succinylcholine 1.0 mg/kg, and then intubated with the appropriate endotracheal tube size (internal diameter of 6.5 or 7 mm with a cuff type of high-volume low pressure). Successful insertion of the endotracheal tube is confirmed by the presence of equal bilateral breath sound. The vital signs (pulse rate, blood pressure, oxygen saturation, and respiratory rate) of the individual parturient are monitored and recorded every 5 minutes for the first 30 minutes and then for every 15 minutes. Any estimated deficit of fluid or blood loss is replaced accordingly. An independent anesthesiologist blinded to the study is asked to inflate the endotracheal tube cuff and determine the cuff pressure using either of the following techniques; standard manometer, predetermined volume of air (10 - 15 ml), or manual palpation of the endotracheal tube pilot balloon immediately after intubation. Again, prior to extubation, the pressure gauge is used to measure the actual pressure generated using the manual palpation of the pilot balloon, or the predetermined volume of air (10 - 15 ml). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Endotracheal tube cuff pressure determined using a standard manometer, predetermined volume of air (10 - 15 ml), or manual palpation of endotracheal tube pilot balloon immediately after intubation or prior to extubation. The technique used and the cuff pressure estimated in each group is recorded 2. Cuff pressure associated complications (cough, sore throat, hoarseness, and blood-streaked expectoration) determined during an interview after 24 hours of extubation |
| Secondary outcome measures | Overall perioperative satisfaction, evaluated as 4 = excellent, 3 = good, 2 = satisfactory, 1 = poor, during an interview on the day of discharge |
| Overall study start date | 01/12/2020 |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | Between 380 and 400 respondents |
| Total final enrolment | 389 |
| Key inclusion criteria | 1. Parturients scheduled for elective cesarean section under general anaesthesia with endotracheal intubation 2. Aged 18 to 40 years 3. American Society of Anesthesiologists Physical Status (ASA-PS) score 1-2 |
| Key exclusion criteria | 1. Patients with a history of difficult intubation or multiple attempts (more than three attempts) during intubation 2. Parturient requiring emergency intubation 3. Parturient with a higher risk for aspiration 4. Intubation performed by non-anaesthesia staff 5. Parturient with known anatomical laryngotracheal abnormalities 6. Those expected to remain intubated beyond the operation room period |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- Ghana
Study participating centres
Tamale
00233
Ghana
Tamale
+233
Ghana
Sponsor information
Hospital/treatment centre
Tamale Northern Region
Tamale
00233
Ghana
| Phone | +233 (0)554470555 |
|---|---|
| habanamedicalservice@gmail.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 22/10/2021: Planned publication in a high-impact peer-reviewed journal. Previous publication and dissemination plan: The researchers will publish the findings of this study in an SCI journal. No additional documents are available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sylvanus Kampo (sylvanuskampo@yahoo.com). |
Editorial Notes
10/11/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/07/2021 to 30/11/2021.
2. The intention to publish date was changed from 30/12/2021 to 10/12/2021.
3. The target number of participants was changed from 'Between 267 and 384 respondents' to 'Between 380 and 400 respondents'.
4. Total final enrolment number added.
22/10/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/02/2021 to 01/06/2021.
2. The recruitment end date has been changed from 30/07/2021 to 30/11/2021.
3. The intention to publish date has been changed from 30/08/2021 to 30/12/2021.
4. The trial participating centre "Habana Medical Center" has been added.
5. The publication and dissemination plan has been updated.
05/07/2021: Trial's existence confirmed by the ethical committee of the University of Health and Allied Sciences.
